Narcotic vs. Non-narcotic Pain Regimens After Pediatric Appendectomy

February 5, 2020 updated by: Sean Stokes, University of Utah

Comparing Narcotic vs. Non-narcotic Pain Regimens After Pediatric Appendectomy: A Randomized Controlled Trial

There is concern that pain prescription after outpatient pediatric surgical procedures is excessive and is in excess of patient need. Current practice following pediatric appendectomy is to prescribe all children with 5-15 doses of narcotic pain medication upon discharge regardless of their age, severity of appendicitis, or pain control in the hospital. This study examines the amount of narcotic pain control required by pediatric patients after undergoing appendectomy using a randomized controlled trial study design.

Pain control will be assessed with a post-operative pain scale, patient satisfaction survey, and parent satisfaction survey on the days following surgery and at post-operative follow-up.

The hypothesis is that the pain scores and patient satisfaction surveys will show no difference in post-operative pain control between the two arms.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

There is concern that pain prescription after outpatient pediatric surgical procedures is excessive and is in excess of patient need. Current practice following pediatric appendectomy is to prescribe all children with 5-15 doses of narcotic pain medication upon discharge regardless of their age, severity of appendicitis, or pain control in the hospital. This study examines the amount of narcotic pain control required by pediatric patients after undergoing appendectomy using a randomized controlled trial study design.

Children admitted after undergoing surgical management for a diagnosis of acute appendicitis will be randomized at discharge to a narcotic arm or a tylenol/motrin arm. The narcotic arm will receive the standard of care narcotic prescription. The tylenol/motrin arm will receive education to use tylenol and motrin for pain control as well as a paper prescription provided for the sole purpose of rescue.

Pain control will be assessed with a post-operative pain scale, patient satisfaction survey, and parent satisfaction survey on the days following surgery and at post-operative follow-up.

The hypothesis is that the pain scores and patient satisfaction surveys will show no difference in post-operative pain control between the two arms.

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

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
    • Utah
      • Salt Lake City, Utah, United States, 84113
        • Primary Children's 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

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children ages 0 to 18 years old
  • Patients have undergone appendectomy by any technique (open, laparoscopic, single-port)

Exclusion Criteria:

  • Patients on chronic opioids
  • Patient undergoes a more extensive or additional procedures at the time of operation due to complications or other indication
  • Pregnancy

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tylenol/Motrin
Group of patients who will receive instructions to use tylenol and motrin for pain control, and parents will be sent home with a paper prescription with a rescue does of standard of care narcotics. They will be instructed to only use the rescue dose if pain is uncontrolled using over the counter medications.
Drug: Non-narcotic pain control
Education to use tylenol and motrin only for pain control unless this is unable to control pain. Rescue prescription provided.
No Intervention: Narcotic
Group of patients who will receive the standard of care narcotic prescription filled upon discharge.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parental pain control satisfaction using Parental Post-operative Pain Measure (PPPM)
Time Frame: 2-week follow-up visit
Parental satisfaction with pain control at home following pediatric appendectomy as assessed by the validated Parental Post-operative Pain Measure (PPPM)
2-week follow-up visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parental pain control satisfaction using Parental Post-operative Pain Measure (PPPM)
Time Frame: Changes from in-hospital, days 1-3 following discharge, and 2-week follow-up
Parental satisfaction with pain control at home following pediatric appendectomy as assessed by Parental Post-operative Pain Measure (PPPM)
Changes from in-hospital, days 1-3 following discharge, and 2-week follow-up
Patient pain control satisfaction using adaptation of Parental Post-operative Pain Measure (PPPM)
Time Frame: Changes from in-hospital, days 1-3 following discharge, and 2-week follow-up
Patient satisfaction with pain control at home following pediatric appendectomy as assessed by an adaptation of Parental Post-operative Pain Measure (PPPM)
Changes from in-hospital, days 1-3 following discharge, and 2-week follow-up
Patient pain scores using Wong-Baker Faces Pain Rating Scale
Time Frame: Changes from in-hospital, days 1-3 following discharge, and 2-week follow-up
Patient description of pain control using validated Wong-Baker Faces Pain Rating Scale. This scale presents the subject with a series of 6 depictions of faces and a text description of pain level. The range is from 0 "No Hurt" to 10 "Hurts Worst".
Changes from in-hospital, days 1-3 following discharge, and 2-week follow-up
Number of pain medications used
Time Frame: Post-operative days 1-14 (until follow-up)
Number of pain medications used
Post-operative days 1-14 (until follow-up)
Days of pain medication requirement after discharge
Time Frame: Post-operative days 1-14 (until follow-up)
Number of days patient required pain medication
Post-operative days 1-14 (until follow-up)
Number of pain medication side effects
Time Frame: Post-operative days 1-14 (until follow-up)
Side effects experienced by taking pain medications following surgery
Post-operative days 1-14 (until follow-up)

Collaborators and Investigators

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

Sponsor

University of Utah

Collaborators

Primary Children's Hospital

Investigators

  • Principal Investigator: Stephen J Fenton, MD, University of Utah, Primary Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

September 5, 2017

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

September 12, 2017

First Submitted That Met QC Criteria

May 4, 2018

First Posted (Actual)

May 17, 2018

Study Record Updates

Last Update Posted (Actual)

February 7, 2020

Last Update Submitted That Met QC Criteria

February 5, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UU83426

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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