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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Withdrawn
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03528343
Enrollment
0
Registered
2018-05-17
Start date
2017-09-05
Completion date
2017-12-01
Last updated
2020-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Appendicitis, Pain, Postoperative

Keywords

appendicitis, postoperative pain, patient satisfaction, children, pediatric, narcotic, pain control

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.

Interventions

DRUGNon-narcotic pain control

Education to use tylenol and motrin only for pain control unless this is unable to control pain. Rescue prescription provided.

Sponsors

Primary Children's Hospital
CollaboratorOTHER
University of Utah
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Parental pain control satisfaction using Parental Post-operative Pain Measure (PPPM)2-week follow-up visitParental satisfaction with pain control at home following pediatric appendectomy as assessed by the validated Parental Post-operative Pain Measure (PPPM)

Secondary

MeasureTime frameDescription
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-upPatient satisfaction with pain control at home following pediatric appendectomy as assessed by an adaptation of Parental Post-operative Pain Measure (PPPM)
Patient pain scores using Wong-Baker Faces Pain Rating ScaleChanges from in-hospital, days 1-3 following discharge, and 2-week follow-upPatient 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.
Parental pain control satisfaction using Parental Post-operative Pain Measure (PPPM)Changes from in-hospital, days 1-3 following discharge, and 2-week follow-upParental satisfaction with pain control at home following pediatric appendectomy as assessed by Parental Post-operative Pain Measure (PPPM)
Days of pain medication requirement after dischargePost-operative days 1-14 (until follow-up)Number of days patient required pain medication
Number of pain medication side effectsPost-operative days 1-14 (until follow-up)Side effects experienced by taking pain medications following surgery
Number of pain medications usedPost-operative days 1-14 (until follow-up)Number of pain medications used

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026