Narcotic vs. Non-narcotic Pain Regimens After Pediatric Appendectomy

Utah System of Higher Education (USHE) logo

Utah System of Higher Education (USHE)

Status and phase

Withdrawn
Phase 2
Phase 1

Conditions

Appendicitis
Pain, Postoperative

Treatments

Drug: Non-narcotic pain control

Study type

Interventional

Funder types

Other

Identifiers

NCT03528343
UU83426

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

Under 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

Tylenol/Motrin
Experimental group
Description:
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.
Treatment:
Drug: Non-narcotic pain control
Narcotic
No Intervention group
Description:
Group of patients who will receive the standard of care narcotic prescription filled upon discharge.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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