Optimization of Pediatric Tonsillectomy to IMprove AnaLgesia

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age3-17
SponsorDuke University

About this trial

The purpose of this study is to compare the use of short acting opioids (fentanyl/hydromorphone) with long acting opioids (methadone) for pain control following tonsillectomy surgery in children and adolescents.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age >= 3 and < 18 years

Elective tonsillectomy +/- adenoidectomy

Signed informed consent by parent or legal guardian

Children >= 12 years must provide signed written consent, Children >= 7 years must provide verbal assent

Disqualifiers

History of chronic kidney or liver disease

Current diagnosis of a chronic pain disorder

Planned admission to the Pediatric Intensive Care Unit (PICU)

Additional procedures under general anesthesia for which opioids would be prescribed

Trial design

Design model

Parallel

Treatments tested in this trial

  • Methadone

    Drug

    Single-dose intraoperative intravenous methadone with initial dose at 0.15 mg/kg in children and 0.2 mg/kg in adolescents.

  • Fentanyl/Hydromorphone

    Drug

    Per routine care, given as needed

Treatment groups

440 Participants
are divided into 2 treatment groups
Group A: Short acting opioids: Fentanyl/HydromorphoneActive comparator 1 intervention
Group B: Long acting opioid: MethadoneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants who required rescue opioid administration in the PACU (post-anesthesia care unit)

Binary (yes/no) need for opioid in the PACU

Time frame
Up to 6 hours post surgery

Secondary outcomes

1

Total amount of opioid medication administered

Postoperative opioid use expressed in morphine milligram equivalents per kilogram

Time frame
Up to 7 days post surgery
2

Opioid administration in the PACU (post-anesthesia care unit)

Postoperative opioid use in the recovery room expressed in morphine milligram equivalents per kilogram

Time frame
Up to 6 hours post surgery
3

Opioid administration post PACU (post-anesthesia care unit)

Postoperative opioid use after PACU discharge expressed in morphine milligram equivalents per kilogram

Time frame
Up to 7 days post surgery
4

Evaluation of participant's pain as measured by Numeric Pain Rating Scale

Numeric Pain Rating Scale, 0-10. 0 no pain, 10 worst possible pain

Time frame
Up to 7 days post surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duke University

Lead sponsor

National Institutes of Health (NIH)

Collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator