The Impact of IV Acetaminophen on Pain After Appendectomy for Perforated Appendicitis

• Sponsor: Children's Mercy Hospital Kansas City (Other)
• Overall Status: Completed
• CT.gov ID: NCT02881996
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 2
• Duration (Months): 26
• Patients Per Site Per Month: 3.5

Study Details

Study Description

Brief Summary

The objective of this study is to evaluate two standard post-operative pain regimens routinely used after laparoscopic appendectomy for perforated appendicitis. The investigators hypothesize that the use of intravenous (IV) acetaminophen in addition to IV ketorolac with narcotic pain pump will decrease time to transition off patient/nurse controlled analgesia (PCA) to oral pain medications.

Condition or Disease	Intervention/Treatment	Phase
Perforated Appendicitis	Drug: IV tylenol; Drug: No IV tylenol; Drug: Ketorolac	N/A

Detailed Description

To assess pain control, patient and family perception of pain control, time to return of bowel function defined as passage of first flatus (in days), doses of anti-emetic medications, doses of narcotic pain medications, time to toleration of regular diet (in days), narcotic associated adverse effects (nausea, emesis, respiratory depression, constipation), length of stay, and overall hospital cost in admission.

Post-hospitalization the investigators will assess complications including number and reasons for emergency visits and abscess formation, length of post-hospitalization analgesic use, length of post-hospitalization narcotic use, and time to return to school.

Study Design

• Study Type: Interventional
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Impact of IV Acetaminophen on Post-operative Pain After Laparoscopic Appendectomy for Perforated Appendicitis: A Prospective Randomized Trial
• Study Start Date: Jun 1, 2014
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IV tylenol Post-operatively, all patients will be placed on a standard patient/nurse controlled analgesia (PCA) according to our pain service protocol which included ketorolac. A 3 hours after first dose of ketorolac, patients in the acetaminophen arm will then receive scheduled 10mg/kg of IV acetaminophen every 6hrs for a total of 3 days in between doses of ketorolac. PCA Pumps will be discontinued with the return of bowel function and transition to oral intake in all patients as per the current protocol. If a patient in the acetaminophen arm is transitioned off of PCA prior to 3 days, IV acetaminophen will be stopped at that time as well. Patients in the control group only may receive oral/rectal acetaminophen as needed for treatment of fevers.	Drug: IV tylenol; IV tylenol given scheduled in addition to standard PCA; Other Names: acetaminophen, ; Drug: Ketorolac; both groups receive as part of our standard postop pain protocol after all operations; Other Names: toradol
Active Comparator: No IV tylenol Same as above without IV tylenol.	Drug: No IV tylenol; No additional IV Tylenol given; Drug: Ketorolac; both groups receive as part of our standard postop pain protocol after all operations; Other Names: toradol

Outcome Measures

Primary Outcome Measures

1. Time Until PCA Discontinued After the Operation [4 days]

   The investigators hypothesize that the use of intravenous (IV) acetaminophen in addition to IV ketorolac with narcotic pain pump will decrease time to transition off PCA/NCA to oral pain medications.

Secondary Outcome Measures

1. Postoperative Duration of Hospital Stay [1 week]

   The investigators will measure postoperative time to discharge

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• All patients ages 2-17 years old undergoing laparoscopic appendectomy at CMH found to have perforated appendicitis.

Exclusion Criteria:

• Non-perforated appendicitis

• Normal appendix at the time of operation or other associated conditions causing abdominal pain

• Patients with history of chronic pain

• Known underlying liver disorders

• Known allergy to pain medication in protocol

• Non-English speaking

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Mercy Hospital	Kansas City	Missouri	United States	64108

Sponsors and Collaborators

• Children's Mercy Hospital Kansas City

Investigators

• Principal Investigator: Shawn D St. Peter, MD, Children's Mercy Hospital Kansas City

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Children's Mercy Hospital Kansas City
• ClinicalTrials.gov Identifier: NCT02881996
• Other Study ID Numbers: 13100328
• First Posted: Aug 29, 2016
• Last Update Posted: Jan 12, 2021
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Children's Mercy Hospital Kansas City: appendicitis; pain; perforation
• Additional relevant MeSH terms: Appendicitis; Acetaminophen; Ketorolac

Study Results

Participant Flow

Arm/Group Title	IV Tylenol	No IV Tylenol
Arm/Group Description	Post-operatively, all patients will be placed on a standard patient/nurse controlled analgesia (PCA) according to our pain service protocol which included ketorolac. A 3 hours after first dose of ketorolac, patients in the acetaminophen arm will then receive scheduled 10mg/kg of IV acetaminophen every 6hrs for a total of 3 days in between doses of ketorolac. PCA Pumps will be discontinued with the return of bowel function and transition to oral intake in all patients as per the current protocol. If a patient in the acetaminophen arm is transitioned off of PCA prior to 3 days, IV acetaminophen will be stopped at that time as well. Patients in the control group only may receive oral/rectal acetaminophen as needed for treatment of fevers. IV tylenol: IV tylenol given scheduled in addition to standard PCA Ketorolac: both groups receive as part of our standard postop pain protocol after all operations	Same as above without IV tylenol. No IV tylenol: No additional IV Tylenol given Ketorolac: both groups receive as part of our standard postop pain protocol after all operations
Period Title: Overall Study
STARTED	45	45
COMPLETED	39	43
NOT COMPLETED	6	2

Baseline Characteristics

Arm/Group Title	IV Tylenol	No IV Tylenol	Total
Arm/Group Description	Post-operatively, all patients will be placed on a standard patient/nurse controlled analgesia (PCA) according to our pain service protocol which included ketorolac. A 3 hours after first dose of ketorolac, patients in the acetaminophen arm will then receive scheduled 10mg/kg of IV acetaminophen every 6hrs for a total of 3 days in between doses of ketorolac. PCA Pumps will be discontinued with the return of bowel function and transition to oral intake in all patients as per the current protocol. If a patient in the acetaminophen arm is transitioned off of PCA prior to 3 days, IV acetaminophen will be stopped at that time as well. Patients in the control group only may receive oral/rectal acetaminophen as needed for treatment of fevers. IV tylenol: IV tylenol given scheduled in addition to standard PCA Ketorolac: both groups receive as part of our standard postop pain protocol after all operations	Same as above without IV tylenol. No IV tylenol: No additional IV Tylenol given Ketorolac: both groups receive as part of our standard postop pain protocol after all operations	Total of all reporting groups
Overall Participants	39	43	82
Age (Count of Participants)
<=18 years	39 100%	43 100%	82 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	10.9	9.6	10.25
Sex: Female, Male (Count of Participants)
Female	14 35.9%	13 30.2%	27 32.9%
Male	25 64.1%	30 69.8%	55 67.1%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	39 100%	43 100%	82 100%

Outcome Measures

1. Primary Outcome

Title	Time Until PCA Discontinued After the Operation
Description	The investigators hypothesize that the use of intravenous (IV) acetaminophen in addition to IV ketorolac with narcotic pain pump will decrease time to transition off PCA/NCA to oral pain medications.
Time Frame	4 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	IV Tylenol	No IV Tylenol
Arm/Group Description	Post-operatively, all patients will be placed on a standard patient/nurse controlled analgesia (PCA) according to our pain service protocol which included ketorolac. A 3 hours after first dose of ketorolac, patients in the acetaminophen arm will then receive scheduled 10mg/kg of IV acetaminophen every 6hrs for a total of 3 days in between doses of ketorolac. PCA Pumps will be discontinued with the return of bowel function and transition to oral intake in all patients as per the current protocol. If a patient in the acetaminophen arm is transitioned off of PCA prior to 3 days, IV acetaminophen will be stopped at that time as well. Patients in the control group only may receive oral/rectal acetaminophen as needed for treatment of fevers. IV tylenol: IV tylenol given scheduled in addition to standard PCA Ketorolac: both groups receive as part of our standard postop pain protocol after all operations	Same as above without IV tylenol. No IV tylenol: No additional IV Tylenol given Ketorolac: both groups receive as part of our standard postop pain protocol after all operations
Measure Participants	39	43
Mean (95% Confidence Interval) [hours]	76.4	86.7

2. Secondary Outcome

Title	Postoperative Duration of Hospital Stay
Description	The investigators will measure postoperative time to discharge
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	IV Tylenol	No IV Tylenol
Arm/Group Description	Post-operatively, all patients will be placed on a standard patient/nurse controlled analgesia (PCA) according to our pain service protocol which included ketorolac. A 3 hours after first dose of ketorolac, patients in the acetaminophen arm will then receive scheduled 10mg/kg of IV acetaminophen every 6hrs for a total of 3 days in between doses of ketorolac. PCA Pumps will be discontinued with the return of bowel function and transition to oral intake in all patients as per the current protocol. If a patient in the acetaminophen arm is transitioned off of PCA prior to 3 days, IV acetaminophen will be stopped at that time as well. Patients in the control group only may receive oral/rectal acetaminophen as needed for treatment of fevers. IV tylenol: IV tylenol given scheduled in addition to standard PCA Ketorolac: both groups receive as part of our standard postop pain protocol after all operations	Same as above without IV tylenol. No IV tylenol: No additional IV Tylenol given Ketorolac: both groups receive as part of our standard postop pain protocol after all operations
Measure Participants	39	43
Median (Inter-Quartile Range) [days]	3.9	4.5

Adverse Events

Time Frame	Duration of length of stay up to one week.
Arm/Group Title	IV Tylenol		No IV Tylenol
Arm/Group Description	Post-operatively, all patients will be placed on a standard patient/nurse controlled analgesia (PCA) according to our pain service protocol which included ketorolac. A 3 hours after first dose of ketorolac, patients in the acetaminophen arm will then receive scheduled 10mg/kg of IV acetaminophen every 6hrs for a total of 3 days in between doses of ketorolac. PCA Pumps will be discontinued with the return of bowel function and transition to oral intake in all patients as per the current protocol. If a patient in the acetaminophen arm is transitioned off of PCA prior to 3 days, IV acetaminophen will be stopped at that time as well. Patients in the control group only may receive oral/rectal acetaminophen as needed for treatment of fevers. IV tylenol: IV tylenol given scheduled in addition to standard PCA Ketorolac: both groups receive as part of our standard postop pain protocol after all operations		Same as above without IV tylenol. No IV tylenol: No additional IV Tylenol given Ketorolac: both groups receive as part of our standard postop pain protocol after all operations
All Cause Mortality
	IV Tylenol		No IV Tylenol
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/39 (0%)		0/43 (0%)
Serious Adverse Events
	IV Tylenol		No IV Tylenol
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/39 (0%)		0/43 (0%)
Other (Not Including Serious) Adverse Events
	IV Tylenol		No IV Tylenol
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/39 (0%)		0/43 (0%)

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.