Clinical trial NCT06576830: Optimization of Pediatric Tonsillectomy to IMprove AnaLgesia
Official title: Single-Dose Intraoperative Methadone for Pain Management in Pediatric Tonsillectomy: A Randomized Double Blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Pain, Postoperative
Tonsillar Hypertrophy
Tonsillitis
Pediatric Sleep Apnea
Sleep-Disordered Breathing
Keywords: Methadone
Tonsillectomy
Opioid
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2024-08-29
Enrollment: 440
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants who required rescue opioid administration in the PACU (post-anesthesia care unit)
timeFrame: Up to 6 hours post surgery
Secondary outcomes:
measure: Total amount of opioid medication administered
timeFrame: Up to 7 days post surgery
measure: Opioid administration in the PACU (post-anesthesia care unit)
timeFrame: Up to 6 hours post surgery
measure: Opioid administration post PACU (post-anesthesia care unit)
timeFrame: Up to 7 days post surgery
measure: Evaluation of participant's pain as measured by Numeric Pain Rating Scale
timeFrame: Up to 7 days post surgery
measure: Number of participants with adverse event in the PACU (post-anesthesia care unit)
timeFrame: Up to 6 hours post surgery
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Lisa M. Einhorn, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Einhorn LM, Hoang J, La JO, Kharasch ED. Single-dose Intraoperative Methadone for Pain Management in Pediatric Tonsillectomy: A Randomized Double-blind Clinical Trial. Anesthesiology. 2024 Sep 1;141(3):463-474. doi: 10.1097/ALN.0000000000005031.