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Clinical Trials/NCT03528343
NCT03528343
Withdrawn
Phase 1

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

University of Utah1 site in 1 countrySeptember 5, 2017

Overview

Phase
Phase 1
Intervention
Non-narcotic pain control
Conditions
Appendicitis
Sponsor
University of Utah
Locations
1
Primary Endpoint
Parental pain control satisfaction using Parental Post-operative Pain Measure (PPPM)
Status
Withdrawn
Last Updated
6 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
September 5, 2017
End Date
December 1, 2017
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sean Stokes

General Surgery Resident

University of Utah

Eligibility Criteria

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

Arms & Interventions

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.

Intervention: Non-narcotic pain control

Outcomes

Primary Outcomes

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)

Secondary Outcomes

  • Patient pain control satisfaction using adaptation of Parental Post-operative Pain Measure (PPPM)(Changes from in-hospital, days 1-3 following discharge, and 2-week follow-up)
  • Parental pain control satisfaction using Parental Post-operative Pain Measure (PPPM)(Changes from in-hospital, days 1-3 following discharge, and 2-week follow-up)
  • Days of pain medication requirement after discharge(Post-operative days 1-14 (until follow-up))
  • Number of pain medication side effects(Post-operative days 1-14 (until follow-up))
  • Patient pain scores using Wong-Baker Faces Pain Rating Scale(Changes from in-hospital, days 1-3 following discharge, and 2-week follow-up)
  • Number of pain medications used(Post-operative days 1-14 (until follow-up))

Study Sites (1)

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