Maxigesic® IV Phase 3 Exposure Study

• Sponsor: AFT Pharmaceuticals, Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04005755
• Collaborator: (none)
• Enrollment: 232
• Locations: 4
• Arm: 1
• Actual Duration (Months): 11.5
• Patients Per Site: 58
• Patients Per Site Per Month: 5

Study Details

Study Description

Brief Summary

The study aims to determine the tolerability of repeated doses of Maxigesic® IV over an extended period of exposure.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Drug: Maxigesic® IV	Phase 3

Detailed Description

Combined administration of acetaminophen and ibuprofen has been shown to provide superior analgesia over administration of comparable doses of either component alone or placebo, when given as an intravenous formulation or as a solid oral tablet in the postoperative setting.

The superior efficacy of the combination does not appear to come at the expense of tolerability. A previous study of Maxigesic® IV in bunionectomy patients found that there were no differences between patients treated with repeated doses of Maxigesic® IV and those treated with intravenous acetaminophen, ibuprofen or placebo in the rate of discontinuations due to adverse events (AEs), the overall incidence of treatment-emergent AEs (TEAEs) or the severity of TEAEs. The incidence of common TEAEs (affecting ≥ 10% of the study population), including gastrointestinal disorders, nervous system disorders, general disorders and administration site conditions, and skin and subcutaneous tissue disorders, was not changed due to combined administration of acetaminophen and ibuprofen in Maxigesic® IV.

This study aims to determine the tolerability of repeated doses of Maxigesic® IV over an extended period of exposure (≥ 48 hours).

Study Design

• Study Type: Interventional
• Actual Enrollment: 232 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 3, Open-Label, Multiple-Dose, Single-Arm Exposure Study of Maxigesic® IV in Patients With Acute Pain Following Orthopedic, General or Plastic Surgery
• Actual Study Start Date: Jul 22, 2019
• Actual Primary Completion Date: Jun 30, 2020
• Actual Study Completion Date: Jul 7, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Maxigesic® IV Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period.	Drug: Maxigesic® IV; acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion

Outcome Measures

Primary Outcome Measures

1. Incidence of TEAEs (Treatment-emergent Adverse Events) [During treatment period (≥ 48 hours - 5 days)]

   The incidence of treatment-emergent adverse events associated with exposure Maxigesic® IV

Secondary Outcome Measures

1. Time Course of TEAEs [After receiving the first dose of study medication until 7 days after the last dose, a total of approximately 9 days for subjects who received the treatment for 48 hours and 12 days for subjects who received the treatment for 5 days.]

   The incidence of treatment-emergent adverse events associated with exposure Maxigesic® IV during various study time periods

2. Incidence of TRAEs (Treatment-related Adverse Events) [During treatment period (≥ 48 hours - 5 days)]

   The incidence of treatment-related adverse events (TEAEs considered by the investigator to be "probably" or "definitely" related to the study drug) associated with exposure Maxigesic® IV

3. Incidence of TEAEs of Interest [During treatment period (≥ 48 hours - 5 days)]

   The incidence of TEAEs of interest (cardiovascular, gastrointestinal, renal, hepatic, administration site conditions and bleeding-related events)

4. Changes in Blood Pressure [From the baseline (Day 1 prior to surgery) until 7 days after the last dose]

   Systolic and Diastolic Blood Pressured Measured every 24 hours

5. Changes in Heart Rate [From the baseline (Day 1 prior to surgery) until 7 days after the last dose]

   Measured every 24 hours

6. Changes in Temperature [From the baseline (Day 1 prior to surgery) until 7 days after the last dose]

   Measured every 24 hours

7. Changes in Respiratory Rate [From the baseline (Day 1 prior to surgery) until 7 days after the last dose]

   Respiratory Rate Measured every 24 hours

8. Changes in Hematology Values (Hemoglobin) [Prior to surgery, on Day 1 and at discharge (Day 5)]

   Measured at screening visit and at the end of the treatment

9. Changes in Hematology Values (Hematocrit) [Prior to surgery, on Day 1 and at discharge (Day 5)]

   Measured at screening visit and at the end of the treatment

10. Changes in Hematology Values (Platelet Count) [Prior to surgery, on Day 1 and at discharge (Day 5)]

    Measured at screening visit and at the end of the treatment

11. Changes in Hematology Values (Red Blood Cell Count) [Prior to surgery, on Day 1 and at discharge (Day 5)]

    Measured at screening visit and at the end of the treatment

12. Changes in Hematology Values (White Blood Cell Count) [Prior to surgery, on Day 1 and at discharge (Day 5)]

    Measured at screening visit and at the end of the treatment

13. Changes in Hematology Values (Differential Leukocyte Count) [Prior to surgery, on Day 1 and at discharge (Day 5)]

    Hematology test was Measured at screening visit and at the end of the treatment

14. Changes in Blood Biochemistry Values (Sodium) [Prior to surgery, on Day 1 and at discharge (Day 5)]

    Measured at screening visit and at the end of the treatment

15. Changes in Blood Biochemistry Values (Potassium) [Prior to surgery, on Day 1 and at discharge (Day 5)]

    Measured at screening visit and at the end of the treatment

16. Changes in Blood Biochemistry Values (Urea) [Prior to surgery, on Day 1 and at discharge (Day 5)]

    Measured at screening visit and at the end of the treatment

17. Changes in Blood Biochemistry Values (Creatinine) [Prior to surgery, on Day 1 and at discharge (Day 5)]

    Measured at screening visit and at the end of the treatment

18. Changes in Blood Biochemistry Values (Phosphate) [Prior to surgery, on Day 1 and at discharge (Day 5)]

    Measured at screening visit and at the end of the treatment

19. Changes in Blood Biochemistry Values (Glucose) [Prior to surgery, on Day 1 and at discharge (Day 5)]

    Measured at screening visit and at the end of the treatment

20. Changes in Blood Biochemistry Values (Albumin) [Prior to surgery, on Day 1 and at discharge (Day 5)]

    Measured at screening visit and at the end of the treatment

21. Changes in Blood Biochemistry Values (Total Protein) [Prior to surgery, on Day 1 and at discharge (Day 5)]

    Measured at screening visit and at the end of the treatment

22. Changes in Blood Biochemistry Values (Alkaline Phosphates) [Prior to surgery, on Day 1 and at discharge (Day 5)]

    Measured at screening visit and at the end of the treatment

23. Changes in Blood Biochemistry Values (Gamma-glutamyl Transferase) [Prior to surgery, on Day 1 and at discharge (Day 5)]

    Blood Biochemistry was Measured at screening visit and at the end of the treatment

24. Changes in Blood Biochemistry Values (Aspartate Transaminase) [Prior to surgery, on Day 1 and at discharge (Day 5)]

    Blood Chemistry (AST) was Measured at screening visit and at the end of the treatment

25. Changes in Blood Biochemistry Values (Alanine Transaminase) [Prior to surgery, on Day 1 and at discharge (Day 5)]

    Blood Chemistry (ALT) was Measured at screening visit and at the end of the treatment

26. Changes in Blood Biochemistry Values (Bilirubin) [Prior to surgery, on Day 1 and at discharge (Day 5)]

    Measured at screening visit and at the end of the treatment

27. Changes in ECG (Electrocardiography) Status (Normal/Abnormal) [Prior to surgery, on Day 1 and at discharge (Day 5)]

    All components of the ECG will be analysed to assess safety (P wave, QRS Complex, QT interval, PR interval, T wave, ST segment, U wave, PR segment) in 5 categories of the shift from baseline to the end of treatment from: Normal to Normal Normal to Abnormal NCS (Non-clinically Significant) Abnormal NCS to Normal Abnormal NCS to Abnormal NCS Missing

28. Changes in Hepatic Enzymes From Baseline to the End of the Treatment [Prior to surgery, on Day 1 and at discharge (Day 5)]

    The elevation in hepatic enzymes (ALP, ALT, AST, GGT) from baseline to the end of the treatment

29. Patient's Global Evaluation of the Study Drug [5 days after the first dose]

    Summary of the patients' ratings of the study medication (1 = Poor; 2 = Fair; 3 = Good; 4 = Very Good; 5 = Excellent)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Is male or female ≥ 18 years of age.

• Is classified by the anesthesiologist as P1 to P2 in the American Society of Anesthesiologists (ASA) Physical Status Classification System.

• Requires multiple doses of parenterally administered nonopioid analgesics over multiple days as a result of surgery (non-laparoscopic general, plastic or orthopedic surgery).

• Has an expected stay in facility ≥ 48 hours.

• Has a body weight ≥ 45 kg.

• If female and of childbearing potential, is nonlactating and nonpregnant.

• If female, is either not of childbearing potential (defined as postmenopausal for at least 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy, or hysterectomy]) or practicing 1 of the following medically acceptable methods of birth control: i) Hormonal methods such as oral, implantable, injectable, or transdermal contraceptives for a minimum of 1 full cycle (based on the subject's usual menstrual cycle period) before study drug administration; ii) Total abstinence from sexual intercourse since the last menses before study drug administration through completion of final study visit; iii) Intrauterine device (IUD); iv) Double-barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream).

• Is able to provide written informed consent to participate in the study and able to understand the procedures and study requirements.

• Must voluntarily sign and date an informed consent form (ICF) that is approved by an Institutional Review Board (IRB) before the conduct of any study procedure.

• Is willing and able to remain at the study site for at least 48 hours and to attend a follow-up visit at 7 ± 2 days after the last dose of study drug.

Exclusion Criteria:

• Has a known history of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, opioids, or any nonsteroidal anti-inflammatory drugs (NSAIDs, including ibuprofen); history of NSAID-induced bronchospasm (subjects with the triad of asthma, nasal polyps, and chronic rhinitis are at greater risk for bronchospasm and should be considered carefully); or hypersensitivity, allergy, or significant reaction to sulfa (including sulfonamide) medicines, ingredients of the study drug, or any other drugs used in the study including anesthetics and antibiotics that may be required on the day of surgery.

• Has experienced any surgical complications or other issues that, in the opinion of the Investigator, could compromise the safety of the subject if he or she participates in the study or could confound the results of the study.

• Has a known or suspected history of alcoholism or drug abuse or misuse within 2 years of screening or evidence of tolerance or physical dependence before dosing with study drug.

• Has any clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, or renal disease or any other condition that, in the opinion of the Investigator, could compromise the subject's welfare, ability to communicate with the study staff, or otherwise contraindicate study participation.

• Has a history or current diagnosis of a significant psychiatric disorder that, in the opinion of the Investigator, would affect the subject's ability to comply with the study requirements.

• Has tested positive either on the urine drug screen or on the alcohol breathalyzer test. Subjects who test positive and can produce a prescription for the medication from their physician may be considered for study enrolment at the discretion of the Investigator.

• Has a history of a clinically significant (Investigator opinion) gastrointestinal (GI) event within 6 months before screening or has any history of peptic or gastric ulcers or GI bleeding.

• Has a surgical or medical condition of the GI or renal system that might significantly alter the absorption, distribution, or excretion of any drug substance.

• Is considered by the Investigator, for any reason to be an unsuitable candidate to receive the study drug.

• Is receiving systemic chemotherapy, has an active malignancy of any type, or has been diagnosed with cancer within 5 years before Screening (excluding treated squamous or basal cell carcinoma of the skin).

• Is currently receiving anticoagulants (e.g. heparin or warfarin).

• Has received a course of systemic corticosteroids (either oral or parenteral) within 3 months before screening (inhaled nasal steroids and regional/limited area application of topical corticosteroids (Investigator discretion) are allowed).

• Has a history of chronic use (defined as daily use for > 2 weeks) of NSAIDs, opiates, or glucocorticoids (except inhaled nasal steroids and regional/limited topical corticosteroids), for any condition within 6 months before study drug administration. Aspirin at a daily dose of ≤ 325 mg is allowed for cardiovascular prophylaxis if the subject has been on a stable dose regimen for ≥ 30 days before screening and has not experienced any relevant medical problem.

• Has a significant renal or hepatic disease, as indicated by clinical laboratory assessment (results ≥ 3 times the upper limit of normal [ULN] for any liver function test, including aspartate aminotransferase [AST], alanine aminotransferase [ALT], or creatinine ≥ 1.5 times the ULN).

• Has any clinically significant laboratory finding at screening that, in the opinion of the Investigator, contraindicates study participation.

• Previously participated in another clinical study of Maxigesic® IV or received any investigational drug or device or investigational therapy within 30 days before Screening.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chesapeake Reserach Group	Pasadena	Maryland	United States	21122
2	Chapel Hill Research Group	Chapel Hill	North Carolina	United States	27514
3	Canterbury Geriatric Medical Research Trust	Christchurch		New Zealand	8083
4	Southern Clinical Trials	Christchurch		New Zealand

Sponsors and Collaborators

• AFT Pharmaceuticals, Ltd.

Investigators

• Principal Investigator: Ira Gottlieb, DPM, Chesapeake Research Group
• Principal Investigator: Simon Carson, MD, Southern Clinical Trials Ltd
• Principal Investigator: Gregory L Ruff, MD, Chapel Hill Research Group
• Principal Investigator: Nigel Gilchrist, MD, CGM Research Trust

Study Documents (Full-Text)

• Study Protocol - Aug 21, 2019
• Statistical Analysis Plan - Oct 7, 2020

More Information

Publications

None provided.

• Responsible Party: AFT Pharmaceuticals, Ltd.
• ClinicalTrials.gov Identifier: NCT04005755
• Other Study ID Numbers: AFT-MXIV-11
• First Posted: Jul 2, 2019
• Last Update Posted: Sep 1, 2021
• Last Verified: Apr 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by AFT Pharmaceuticals, Ltd.: Analgesic
• Additional relevant MeSH terms: Pain, Postoperative

Study Results

Participant Flow

Recruitment Details

323 subjects were screened, of whom 90 subjects were screening failures, and a total of 233 subjects were enrolled. 1 subject was enrolled but not dosed due to receiving prohibited concomitant medications during surgery, therefore a total of 232 subjects were administered at least one dose of the study drug. 17 subjects discontinued from the study, including 14 discontinuations during the treatment period, and 3 discontinuations during the follow-up period. 215 subjects completed the full study

Arm/Group Title	Maxigesic® IV
Arm/Group Description	Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period. Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
Period Title: Overall Study
STARTED	232
COMPLETED	215
NOT COMPLETED	17

Baseline Characteristics

Arm/Group Title	Maxigesic® IV
Arm/Group Description	Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period. Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
Overall Participants	232
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	171 73.7%
>=65 years	61 26.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.4 (15.3)
Sex: Female, Male (Count of Participants)
Female	144 62.1%
Male	88 37.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	8 3.4%
Not Hispanic or Latino	223 96.1%
Unknown or Not Reported	1 0.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	3 1.3%
Asian	1 0.4%
Native Hawaiian or Other Pacific Islander	3 1.3%
Black or African American	91 39.2%
White	131 56.5%
More than one race	3 1.3%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
New Zealand	85 36.6%
United States	147 63.4%
BMI (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	29.7 (5.5)

Outcome Measures

1. Primary Outcome

Title	Incidence of TEAEs (Treatment-emergent Adverse Events)
Description	The incidence of treatment-emergent adverse events associated with exposure Maxigesic® IV
Time Frame	During treatment period (≥ 48 hours - 5 days)

Outcome Measure Data

Analysis Population Description

The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received.

Arm/Group Title	Maxigesic® IV
Arm/Group Description	Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period. Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
Measure Participants	232
Incidence of TEAEs ( 2 days treatment)	256
Incidence of TEAEs (5 days treatment)	38

2. Secondary Outcome

Title	Time Course of TEAEs
Description	The incidence of treatment-emergent adverse events associated with exposure Maxigesic® IV during various study time periods
Time Frame	After receiving the first dose of study medication until 7 days after the last dose, a total of approximately 9 days for subjects who received the treatment for 48 hours and 12 days for subjects who received the treatment for 5 days.

Outcome Measure Data

Analysis Population Description

The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received.

Arm/Group Title	Maxigesic® IV
Arm/Group Description	Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period. Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
Measure Participants	232
Treatment-Emergent Adverse Events Day 1	166
Treatment-Emergent Adverse Events Day 2	90
Treatment-Emergent Adverse Events Day 3	9
Treatment-Emergent Adverse Events Day 4	12
Treatment-Emergent Adverse Events Day 5	17

3. Secondary Outcome

Title	Incidence of TRAEs (Treatment-related Adverse Events)
Description	The incidence of treatment-related adverse events (TEAEs considered by the investigator to be "probably" or "definitely" related to the study drug) associated with exposure Maxigesic® IV
Time Frame	During treatment period (≥ 48 hours - 5 days)

Outcome Measure Data

Analysis Population Description

The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received.

Arm/Group Title	Maxigesic® IV
Arm/Group Description	Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period. Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
Measure Participants	232
Not related	103
Unlikely	89
Possible	34
Probable	17
Definite	51

4. Secondary Outcome

Title	Incidence of TEAEs of Interest
Description	The incidence of TEAEs of interest (cardiovascular, gastrointestinal, renal, hepatic, administration site conditions and bleeding-related events)
Time Frame	During treatment period (≥ 48 hours - 5 days)

Outcome Measure Data

Analysis Population Description

The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received.

Arm/Group Title	Maxigesic® IV
Arm/Group Description	Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period. Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
Measure Participants	232
Gastrointestinal disorders	67
Renal and urinary disorders	12
Abnormal hepatic function lab results	25
General disorders and administration site conditions	78
Cardiac Disorders	3
Vascular disorders	7

5. Secondary Outcome

Title	Changes in Blood Pressure
Description	Systolic and Diastolic Blood Pressured Measured every 24 hours
Time Frame	From the baseline (Day 1 prior to surgery) until 7 days after the last dose

Outcome Measure Data

Analysis Population Description

The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received.

Arm/Group Title	Maxigesic® IV
Arm/Group Description	Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period. Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
Measure Participants	232
Systolic Blood Pressure change from the baseline	-0.9 (18.98)
Diastolic Blood Pressure change from the baseline	-0.5 (11.31)

6. Secondary Outcome

Title	Changes in Heart Rate
Description	Measured every 24 hours
Time Frame	From the baseline (Day 1 prior to surgery) until 7 days after the last dose

Outcome Measure Data

Analysis Population Description

The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received.

Arm/Group Title	Maxigesic® IV
Arm/Group Description	Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period. Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
Measure Participants	232
Mean (Standard Deviation) [beats/min]	3.4 (11.86)

7. Secondary Outcome

Title	Changes in Temperature
Description	Measured every 24 hours
Time Frame	From the baseline (Day 1 prior to surgery) until 7 days after the last dose

Outcome Measure Data

Analysis Population Description

The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received.

Arm/Group Title	Maxigesic® IV
Arm/Group Description	Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period. Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
Measure Participants	232
Mean (Standard Deviation) [degree Celsius]	0.2 (0.38)

8. Secondary Outcome

Title	Changes in Respiratory Rate
Description	Respiratory Rate Measured every 24 hours
Time Frame	From the baseline (Day 1 prior to surgery) until 7 days after the last dose

Outcome Measure Data

Analysis Population Description

The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received.

Arm/Group Title	Maxigesic® IV
Arm/Group Description	Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period. Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
Measure Participants	232
Mean (Standard Deviation) [breaths/min]	0.5 (2.43)

9. Secondary Outcome

Title	Changes in Hematology Values (Hemoglobin)
Description	Measured at screening visit and at the end of the treatment
Time Frame	Prior to surgery, on Day 1 and at discharge (Day 5)

Outcome Measure Data

Analysis Population Description

The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received.

Arm/Group Title	Maxigesic® IV
Arm/Group Description	Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period. Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
Measure Participants	232
Mean (Standard Deviation) [g/L]	-11.6 (13.4)

10. Secondary Outcome

Title	Changes in Hematology Values (Hematocrit)
Description	Measured at screening visit and at the end of the treatment
Time Frame	Prior to surgery, on Day 1 and at discharge (Day 5)

Outcome Measure Data

Analysis Population Description

The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received.

Arm/Group Title	Maxigesic® IV
Arm/Group Description	Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period. Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
Measure Participants	232
Mean (Standard Deviation) [proportion of red blood cells in blood]	-0.03 (0.04)

11. Secondary Outcome

Title	Changes in Hematology Values (Platelet Count)
Description	Measured at screening visit and at the end of the treatment
Time Frame	Prior to surgery, on Day 1 and at discharge (Day 5)

Outcome Measure Data

Analysis Population Description

The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received.

Arm/Group Title	Maxigesic® IV
Arm/Group Description	Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period. Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
Measure Participants	232
Mean (Standard Deviation) [billions/L]	-12.8 (40.1)

12. Secondary Outcome

Title	Changes in Hematology Values (Red Blood Cell Count)
Description	Measured at screening visit and at the end of the treatment
Time Frame	Prior to surgery, on Day 1 and at discharge (Day 5)

Outcome Measure Data

Analysis Population Description

The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received

Arm/Group Title	Maxigesic® IV
Arm/Group Description	Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period. Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
Measure Participants	232
Mean (Standard Deviation) [trillions/L]	-0.4 (0.5)

13. Secondary Outcome

Title	Changes in Hematology Values (White Blood Cell Count)
Description	Measured at screening visit and at the end of the treatment
Time Frame	Prior to surgery, on Day 1 and at discharge (Day 5)

Outcome Measure Data

Analysis Population Description

The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received.

Arm/Group Title	Maxigesic® IV
Arm/Group Description	Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period. Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
Measure Participants	232
Mean (Standard Deviation) [billions/L]	6.2 (1.7)

14. Secondary Outcome

Title	Changes in Hematology Values (Differential Leukocyte Count)
Description	Hematology test was Measured at screening visit and at the end of the treatment
Time Frame	Prior to surgery, on Day 1 and at discharge (Day 5)

Outcome Measure Data

Analysis Population Description

The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received

Arm/Group Title	Maxigesic® IV
Arm/Group Description	Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period. Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
Measure Participants	232
Basophils	-0.00 (0.02)
Eosinophils	0.05 (0.13)
Lymphocytes	-0.2 (0.5)
Monocytes	0.2 (0.2)
Neutrophils	1.5 (1.7)

15. Secondary Outcome

Title	Changes in Blood Biochemistry Values (Sodium)
Description	Measured at screening visit and at the end of the treatment
Time Frame	Prior to surgery, on Day 1 and at discharge (Day 5)

Outcome Measure Data

Analysis Population Description

The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received.

Arm/Group Title	Maxigesic® IV
Arm/Group Description	Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period. Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
Measure Participants	232
Mean (Standard Deviation) [mmol/L]	-0.6 (2.3)

16. Secondary Outcome

Title	Changes in Blood Biochemistry Values (Potassium)
Description	Measured at screening visit and at the end of the treatment
Time Frame	Prior to surgery, on Day 1 and at discharge (Day 5)

Outcome Measure Data

Analysis Population Description

The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received.

Arm/Group Title	Maxigesic® IV
Arm/Group Description	Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period. Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
Measure Participants	232
Mean (Standard Deviation) [mmol/L]	-0.1 (0.4)

17. Secondary Outcome

Title	Changes in Blood Biochemistry Values (Urea)
Description	Measured at screening visit and at the end of the treatment
Time Frame	Prior to surgery, on Day 1 and at discharge (Day 5)

Outcome Measure Data

Analysis Population Description

The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received.

Arm/Group Title	Maxigesic® IV
Arm/Group Description	Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period. Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
Measure Participants	232
Mean (Standard Deviation) [mmol/L]	-0.7 (1.4)

18. Secondary Outcome

Title	Changes in Blood Biochemistry Values (Creatinine)
Description	Measured at screening visit and at the end of the treatment
Time Frame	Prior to surgery, on Day 1 and at discharge (Day 5)

Outcome Measure Data

Analysis Population Description

The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received.

Arm/Group Title	Maxigesic® IV
Arm/Group Description	Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period. Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
Measure Participants	232
Mean (Standard Deviation) [μmol/L]	-3.9 (9.5)

19. Secondary Outcome

Title	Changes in Blood Biochemistry Values (Phosphate)
Description	Measured at screening visit and at the end of the treatment
Time Frame	Prior to surgery, on Day 1 and at discharge (Day 5)

Outcome Measure Data

Analysis Population Description

The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received.

Arm/Group Title	Maxigesic® IV
Arm/Group Description	Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period. Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
Measure Participants	232
Mean (Standard Deviation) [mmol/L]	-0.1 (0.2)

20. Secondary Outcome

Title	Changes in Blood Biochemistry Values (Glucose)
Description	Measured at screening visit and at the end of the treatment
Time Frame	Prior to surgery, on Day 1 and at discharge (Day 5)

Outcome Measure Data

Analysis Population Description

The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received.

Arm/Group Title	Maxigesic® IV
Arm/Group Description	Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period. Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
Measure Participants	232
Mean (Standard Deviation) [mmol/L]	0.7 (1.5)

21. Secondary Outcome

Title	Changes in Blood Biochemistry Values (Albumin)
Description	Measured at screening visit and at the end of the treatment
Time Frame	Prior to surgery, on Day 1 and at discharge (Day 5)

Outcome Measure Data

Analysis Population Description

The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received.

Arm/Group Title	Maxigesic® IV
Arm/Group Description	Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period. Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
Measure Participants	232
Mean (Standard Deviation) [g/L]	-4.9 (3.2)

22. Secondary Outcome

Title	Changes in Blood Biochemistry Values (Total Protein)
Description	Measured at screening visit and at the end of the treatment
Time Frame	Prior to surgery, on Day 1 and at discharge (Day 5)

Outcome Measure Data

Analysis Population Description

The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received.

Arm/Group Title	Maxigesic® IV
Arm/Group Description	Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period. Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
Measure Participants	232
Mean (Standard Deviation) [g/L]	-5.8 (5.3)

23. Secondary Outcome

Title	Changes in Blood Biochemistry Values (Alkaline Phosphates)
Description	Measured at screening visit and at the end of the treatment
Time Frame	Prior to surgery, on Day 1 and at discharge (Day 5)

Outcome Measure Data

Analysis Population Description

The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received.

Arm/Group Title	Maxigesic® IV
Arm/Group Description	Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period. Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
Measure Participants	232
Mean (Standard Deviation) [IU/L]	-2.1 (15.1)

24. Secondary Outcome

Title	Changes in Blood Biochemistry Values (Gamma-glutamyl Transferase)
Description	Blood Biochemistry was Measured at screening visit and at the end of the treatment
Time Frame	Prior to surgery, on Day 1 and at discharge (Day 5)

Outcome Measure Data

Analysis Population Description

The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received.

Arm/Group Title	Maxigesic® IV
Arm/Group Description	Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period. Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
Measure Participants	232
Mean (Standard Deviation) [IU/L]	4.3 (16.5)

25. Secondary Outcome

Title	Changes in Blood Biochemistry Values (Aspartate Transaminase)
Description	Blood Chemistry (AST) was Measured at screening visit and at the end of the treatment
Time Frame	Prior to surgery, on Day 1 and at discharge (Day 5)

Outcome Measure Data

Analysis Population Description

The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received.

Arm/Group Title	Maxigesic® IV
Arm/Group Description	Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period. Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
Measure Participants	232
Mean (Standard Deviation) [IU/L]	7.1 (23.3)

26. Secondary Outcome

Title	Changes in Blood Biochemistry Values (Alanine Transaminase)
Description	Blood Chemistry (ALT) was Measured at screening visit and at the end of the treatment
Time Frame	Prior to surgery, on Day 1 and at discharge (Day 5)

Outcome Measure Data

Analysis Population Description

The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received.

Arm/Group Title	Maxigesic® IV
Arm/Group Description	Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period. Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
Measure Participants	232
Mean (Standard Deviation) [IU/L]	4.5 (25.2)

27. Secondary Outcome

Title	Changes in Blood Biochemistry Values (Bilirubin)
Description	Measured at screening visit and at the end of the treatment
Time Frame	Prior to surgery, on Day 1 and at discharge (Day 5)

Outcome Measure Data

Analysis Population Description

The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received.

Arm/Group Title	Maxigesic® IV
Arm/Group Description	Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period. Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
Measure Participants	232
Mean (Standard Deviation) [μmol/L]	0.0 (3.9)

28. Secondary Outcome

Title	Changes in ECG (Electrocardiography) Status (Normal/Abnormal)
Description	All components of the ECG will be analysed to assess safety (P wave, QRS Complex, QT interval, PR interval, T wave, ST segment, U wave, PR segment) in 5 categories of the shift from baseline to the end of treatment from: Normal to Normal Normal to Abnormal NCS (Non-clinically Significant) Abnormal NCS to Normal Abnormal NCS to Abnormal NCS Missing
Time Frame	Prior to surgery, on Day 1 and at discharge (Day 5)

Outcome Measure Data

Analysis Population Description

The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received.

Arm/Group Title	Maxigesic® IV
Arm/Group Description	Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period. Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
Measure Participants	232
Shift from Baseline to the end of treatment Missing	2 0.9%
Shift from Baseline to the end of treatment Normal to Normal	83 35.8%
Shift from Baseline to the end of treatment Normal to Abnormal NCS	18 7.8%
Shift from Baseline to the end of treatment Abnormal NCS to Normal	44 19%
Shift from Baseline to the end of treatment Abnormal NCS to Abnormal NCS	85 36.6%

29. Secondary Outcome

Title	Changes in Hepatic Enzymes From Baseline to the End of the Treatment
Description	The elevation in hepatic enzymes (ALP, ALT, AST, GGT) from baseline to the end of the treatment
Time Frame	Prior to surgery, on Day 1 and at discharge (Day 5)

Outcome Measure Data

Analysis Population Description

The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received. The number of participants analyzed are reporting the number of participants who experienced the shifts from Normal to Abnormal.

Arm/Group Title	Maxigesic® IV
Arm/Group Description	Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period. Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
Measure Participants	232
ALP	1 0.4%
ALT	24 10.3%
AST	22 9.5%
GGT	12 5.2%
ALP	0 0%
ALT	4 1.7%
AST	5 2.2%
GGT	0 0%
ALP	0 0%
ALT	2 0.9%
AST	0 0%
GGT	0 0%

30. Secondary Outcome

Title	Patient's Global Evaluation of the Study Drug
Description	Summary of the patients' ratings of the study medication (1 = Poor; 2 = Fair; 3 = Good; 4 = Very Good; 5 = Excellent)
Time Frame	5 days after the first dose

Outcome Measure Data

Analysis Population Description

The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received.

Arm/Group Title	Maxigesic® IV
Arm/Group Description	Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period. Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
Measure Participants	232
Poor	4 1.7%
Fair	12 5.2%
Good	40 17.2%
Very Good	82 35.3%
Excellent	93 40.1%
Missing	1 0.4%

Adverse Events

Time Frame	During the treatment period (after receiving the first dose of study medication until 7 days after the last dose, a total of approximately 12 days)
Adverse Event Reporting Description	Treatment-emergent adverse events (TEAEs): Treatment-emergent adverse events (TEAEs) were defined as events that emerged during treatment, having been absent pre-treatment, or that worsened relative to the pre-treatment status. The definition of serious adverse events and reporting requirement are determined in the study protocol section 8.1.2 and section 8.4
Arm/Group Title	Maxigesic® IV
Arm/Group Description	Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period. Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
All Cause Mortality
	Maxigesic® IV
	Affected / at Risk (%)	# Events
Total	0/232 (0%)
Serious Adverse Events
	Maxigesic® IV
	Affected / at Risk (%)	# Events
Total	2/232 (0.9%)
Gastrointestinal disorders
bowel obstruction	1/232 (0.4%)	1
Vascular disorders
hypotension	1/232 (0.4%)	1
Other (Not Including Serious) Adverse Events
	Maxigesic® IV
	Affected / at Risk (%)	# Events
Total	164/232 (70.7%)
Gastrointestinal disorders
Nausea	28/232 (12.1%)	32
Constipation	18/232 (7.8%)	19
General disorders
Infusion site pain	44/232 (19%)	49
Infusion site extravasation	18/232 (7.8%)	19
Hepatobiliary disorders
Alanine aminotransferase increased	5/232 (2.2%)	5
Injury, poisoning and procedural complications
Procedural nausea	8/232 (3.4%)	8
Nervous system disorders
Headache	13/232 (5.6%)	13
Dizziness	9/232 (3.9%)	12
Somnolence	7/232 (3%)	7
Diarrhoea	5/232 (2.2%)	5
Renal and urinary disorders
Polyuria	9/232 (3.9%)	9

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.