Ibuprofen IV vs Acetaminophen IV for the Treatment of Pain Following Orthopaedic Low Extremity Surgery

Sponsor

Indonesia University (Other)

Overall Status

Completed

CT.gov ID

NCT03771755

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

12.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to evaluate the efficacy of IV Ibuprofen versus IV Acetaminophen in the reduction of pain following orthopedic low extremity procedures

Condition or Disease	Intervention/Treatment	Phase
Lower Extremity Problem Surgery Postoperative Pain	Drug: Ibuprofen Drug: Acetaminophen	N/A

Detailed Description

Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Patients undergoing orthopedic low extremity surgery were screened. Eligible subjects were then randomized into treatment group (intravenous ibuprofen) and control group (intravenous acetaminophen). In case required, patients from both group will be given Morphine (PCA) 1-2 mg every 5 minutes.

Study Design

Study Type:

Interventional

Actual Enrollment :

62 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Supportive Care

Official Title:

A Prospective, Randomized, Double-blind Study Assessing the Efficacy of Intravenous (IV) Ibuprofen Versus IV Acetaminophen for the Treatment of Pain Following Orthopaedic Low Extremity Surgery

Actual Study Start Date :

Jul 1, 2017

Actual Primary Completion Date :

Nov 30, 2017

Actual Study Completion Date :

Nov 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ibuprofen group 800 mg IV - Ibuprofen every 6 hours. In case required - followed with Morphine (PCA) 1-2 mg every 5 minutes	Drug: Ibuprofen 800 mg IV - Ibuprofen every 6 hours. In case required - followed with Morphine (PCA) 1-2 mg every 5 minutes
Placebo Comparator: Acetaminophen group 1000mg IV Acetaminophen every 6 hours. In case required - followed with Morphine (PCA) 1-2 mg every 5 minutes	Drug: Acetaminophen 1000mg IV Acetaminophen every 6 hours. In case required - followed with Morphine (PCA) 1-2 mg every 5 minutes

Arm

Intervention/Treatment

Active Comparator: Ibuprofen group

800 mg IV - Ibuprofen every 6 hours. In case required - followed with Morphine (PCA) 1-2 mg every 5 minutes

Drug: Ibuprofen

800 mg IV - Ibuprofen every 6 hours. In case required - followed with Morphine (PCA) 1-2 mg every 5 minutes

Placebo Comparator: Acetaminophen group

1000mg IV Acetaminophen every 6 hours. In case required - followed with Morphine (PCA) 1-2 mg every 5 minutes

Drug: Acetaminophen

1000mg IV Acetaminophen every 6 hours. In case required - followed with Morphine (PCA) 1-2 mg every 5 minutes

Outcome Measures

Primary Outcome Measures

Pain intensity [24 hours]
demonstrated by the measurement VAS (Visual Analog Scale) for 24 hrs postoperative.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Scheduled for Orthopedic Low Extremity Surgery with general anesthesia and anticipated need post operative IV analgesia with anticipated use of >48 hours.
Adequate IV access.
Anticipated hospital stay>48 hours.
Age 18-70 years old with physical status ASA I- III.
Patients able to fill informed consent sheet.

Exclusion Criteria:

patients with use of analgesia, muscle relaxants, NSAIDs and sedatives less than 24 hours to study drug administration
anemia (active, clinically significant anemia) and/or a history or evidence of asthma or heart failure
historical or at higher risk intracerebral bleeding, history of allergy or hypersensitive to NSAID, Ibuprofen, Acetaminophen or opioid
pregnant or nursing
body weight less than 30 kg
any active clinically significant bleeding or have underlying platelet dysfunction and/or receiving full dose anticoagulation therapy
GI bleeding that required medical intervention within the previous 6 weeks (unless definitive surgery has been performed)
on dialysis or renal dysfunction
impaired liver function
inability to achieve hemostasis or inability to close surgical incision prior to operating room discharge
operative procedure includes organ transplant, pre-and intra- operative procedure utilized for the prevention of pre- or post-operative pain (i.e, epidural or nerve blocks)
received anoher investigational drug within the past 30 days
known or suspected history of alcohol or drug abuse
severe infection and/or inflammatory disease