IRB-HSR# 14145 R,S Methadone: Analgesia and Pharmacokinetics in Adolescents Undergoing Scoliosis Correction

Phase 3

Completed

• Conditions: Scoliosis
• Interventions: Drug: methadone

• Registration Number: NCT01205256
• Lead Sponsor: University of Virginia

Brief Summary

This is a pilot study to determine the pharmacokinetics of (R,S) methadone in adolescents. A total of approximately 15 patients will be required. The purpose is to determine the levels of R, S methadone at various time intervals after drug administration. Patients will receive methadone 0.25 mg/kg IV at induction and a standardized anesthetic of remifentanil and propofol. At the conclusion of surgery (45 minutes prior to the completion), the patients will receive a loading dose of morphine based on respiratory rate. A morphine PCA will be utilized for postoperative analgesia. Pharmacokinetic data will be collected in addition to VAS scores, patient and parental satisfaction with analgesia, and a functional pain assessment.

Detailed Description

Study Procedures Following Surgery:

* VAS scores will be recorded at intervals of 1,2,3,4,5,6,8,12,16,20,24, 36, 48 , 72 hrs (after extubation).

* Blood samples for PK will require 5ml per sample and may be obtained from an existing IV or direct phlebotomy and will be obtained at 0min, 5min, 10 min, 15min, 20 min, 40 min, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10 hrs, 12hrs, 24hrs, 48 hrs, 72hrs, and 96hrs after study drug administration.

Study Timeline

• Study Start: 2009-03
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Study First Submitted: 2010-09-16
• Study First Submitted QC: 2010-09-17
• Study First Posted: 2010-09-20
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-01
• Last Update Posted: 2016-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• Pediatric scoliosis surgery secondary idiopathic scoliosis, congenital scoliosis,
• Age 12 - 19 inclusive
• ASA class I-II.

Exclusion Criteria

• Preoperative opioid therapy in previous 2 weeks
• Known hepatic or renal impairment
• Inability to assess pain score due to neurological impairment, hearing impairment
• Allergy to methadone, morphine, fentanyl, propofol or remifentanil
• Pregnant or nursing
• Taking SSRI's, MAOI,anticonvulsants, gabapentin or lyrica
• ASA III or greater patients are excluded
• pre-existing chronic pain

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Methadone	methadone	0.25mg/kg IV of racemic methadone at the induction of anesthesia.

Primary Outcome Measures

Name	Time	Method
methadone levels	0min, 5min, 10 min, 15min, 20 min, 40 min, 1, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10 hrs, 12hrs, 24hrs, 48 hrs, 72hrs, and 96hrs.	Tmax (time to maximum methadone concentration) Cmax (maximum concentration) T1/2 (half-life) AUC last (area under the curve from time 0 to last sample point) AUC inf (area under the curve from time 0 to infinity) VZ (Volume of distribution in the terminal phase) CL (clearance)

Trial Locations

Locations (1)

University of Virginia Health System; 🇺🇸 Charlottesville, Virginia, United States