MedPath

Narcotic vs. Non-narcotic Pain Regimens After Pediatric Appendectomy

Phase 1
Withdrawn
Conditions
Appendicitis
Pain, Postoperative
Interventions
Drug: Non-narcotic pain control
Registration Number
NCT03528343
Lead Sponsor
University of Utah
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.

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
Inclusion Criteria
  • Children ages 0 to 18 years old
  • Patients have undergone appendectomy by any technique (open, laparoscopic, single-port)
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Tylenol/MotrinNon-narcotic pain controlGroup 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.
Primary Outcome Measures
NameTimeMethod
Parental pain control satisfaction using Parental Post-operative Pain Measure (PPPM)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 Outcome Measures
NameTimeMethod
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

Patient satisfaction with pain control at home following pediatric appendectomy as assessed by an adaptation of Parental Post-operative Pain Measure (PPPM)

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

Parental 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

Patient pain scores using Wong-Baker Faces Pain Rating ScaleChanges 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".

Number of pain medications usedPost-operative days 1-14 (until follow-up)

Number of pain medications used

Trial Locations

Locations (1)

Primary Children's Hospital

🇺🇸

Salt Lake City, Utah, United States

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