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

December 18, 2020 updated by: Children's Mercy Hospital Kansas City

Impact of IV Acetaminophen on Post-operative Pain After Laparoscopic Appendectomy for Perforated Appendicitis: A Prospective Randomized Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Children's Mercy Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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: Ketorolac
both groups receive as part of our standard postop pain protocol after all operations
Other Names:
  • toradol
Drug: No IV tylenol
No additional IV Tylenol given

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time Until PCA Discontinued After the Operation
Time Frame: 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.
4 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Mercy Hospital Kansas City

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (ACTUAL)

June 1, 2016

Study Completion (ACTUAL)

August 1, 2016

Study Registration Dates

First Submitted

January 18, 2016

First Submitted That Met QC Criteria

August 26, 2016

First Posted (ESTIMATE)

August 29, 2016

Study Record Updates

Last Update Posted (ACTUAL)

January 12, 2021

Last Update Submitted That Met QC Criteria

December 18, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13100328

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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