NCT03528343

Narcotic vs. Non-narcotic Pain Regimens After Pediatric Appendectomy

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

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Appendicitis
• Pain, Postoperative

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-09-05
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2018-05-17
• Last updated: 2020-02-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study