Clinical trial NCT03528343: Narcotic vs. Non-narcotic Pain Regimens After Pediatric Appendectomy
Official title: Comparing Narcotic vs. Non-narcotic Pain Regimens After Pediatric Appendectomy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Appendicitis
Pain, Postoperative
Keywords: appendicitis
postoperative pain
patient satisfaction
children
pediatric
narcotic
pain control
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Primary Children's Hospital
First posted: 2018-05-17
Enrollment: 0
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Parental pain control satisfaction using Parental Post-operative Pain Measure (PPPM)
timeFrame: 2-week follow-up visit
Secondary outcomes:
measure: Parental pain control satisfaction using Parental Post-operative Pain Measure (PPPM)
timeFrame: Changes from in-hospital, days 1-3 following discharge, and 2-week follow-up
measure: Patient pain control satisfaction using adaptation of Parental Post-operative Pain Measure (PPPM)
timeFrame: Changes from in-hospital, days 1-3 following discharge, and 2-week follow-up
measure: Patient pain scores using Wong-Baker Faces Pain Rating Scale
timeFrame: Changes from in-hospital, days 1-3 following discharge, and 2-week follow-up
measure: Number of pain medications used
timeFrame: Post-operative days 1-14 (until follow-up)
measure: Days of pain medication requirement after discharge
timeFrame: Post-operative days 1-14 (until follow-up)
measure: Number of pain medication side effects
timeFrame: Post-operative days 1-14 (until follow-up)
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Primary Children's Hospital
state: Utah
Study officials:
affiliation: University of Utah, Primary Children's Hospital
name: Stephen J Fenton, MD
role: PRINCIPAL_INVESTIGATOR
References:
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