Pain, Postoperative, Tonsillar Hypertrophy, Tonsillitis, Pediatric Sleep Apnea, Sleep-Disordered Breathing
Conditions
Keywords
Methadone, Tonsillectomy, Opioid
Brief summary
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.
Detailed description
This is a randomized, double-blind, parallel-group, dose-escalation investigation. Participants (children defined as ages 3 - \< 12 years and adolescents defined as ages 12 - 17 years) will be randomized 2:1 to either methadone or short-acting opioid. Surgical and anesthesia care, except for intraoperative opioid management, are not altered for study purposes. The trial will include 2 periods in 3 parallel age groups. In the first period, each age cohort will recruit 66 patients (44 methadone, 22 control). Children will be randomized to methadone 0.15 mg/kg age-ideal body weight and adolescents to 0.2 mg/kg age-ideal body weight. When an age cohort reaches 66 patients, this is the end of the first period. At that time, an unblinded interim analysis will be conducted in that cohort to determine if dose escalation to 0.2 mg/kg dose in children and the 0.25 mg/kg dose in adolescents are met. Methadone dose escalation will be based on clinically meaningful differences in need for rescue opioid in the PACU and the absence of well-defined opioid adverse events. Outcomes data will be collected in hospital and after discharge. With daily surveys for 7 days, and 3 phone calls on day 30, 3 months and 6 months after surgery.
Interventions
DRUGMethadone
Single-dose intraoperative intravenous methadone with initial dose at 0.15 mg/kg in children and 0.2 mg/kg in adolescents.
Per routine care, given as needed
Sponsors
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age \>= 3 and \< 18 years 2. Elective tonsillectomy +/- adenoidectomy 3. Signed informed consent by parent or legal guardian 4. Children \>= 12 years must provide signed written consent, Children \>= 7 years must provide verbal assent 5. Negative pregnancy test within 48 hours for post pubescent females
Exclusion criteria
1. History of chronic kidney or liver disease 2. Current diagnosis of a chronic pain disorder 3. Planned admission to the Pediatric Intensive Care Unit (PICU) 4. Additional procedures under general anesthesia for which opioids would be prescribed
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who required rescue opioid administration in the PACU (post-anesthesia care unit) | Up to 6 hours post surgery | Binary (yes/no) need for opioid in the PACU |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total amount of opioid medication administered | Up to 7 days post surgery | Postoperative opioid use expressed in morphine milligram equivalents per kilogram |
| Opioid administration in the PACU (post-anesthesia care unit) | Up to 6 hours post surgery | Postoperative opioid use in the recovery room expressed in morphine milligram equivalents per kilogram |
| Opioid administration post PACU (post-anesthesia care unit) | Up to 7 days post surgery | Postoperative opioid use after PACU discharge expressed in morphine milligram equivalents per kilogram |
| Evaluation of participant's pain as measured by Numeric Pain Rating Scale | Up to 7 days post surgery | Numeric Pain Rating Scale, 0-10. 0 no pain, 10 worst possible pain |
| Number of participants with adverse event in the PACU (post-anesthesia care unit) | Up to 6 hours post surgery | Adverse events will only include those that are determined to be related to the study drugs. |
Countries
United States
Contacts
Primary ContactLisa M Einhorn, MD
Outcome results
None listed