Methadone in Pediatric Anesthesiology II

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-10

Study Completion Date

2018-06-30

Brief Summary

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Three arm randomized controlled trial to evaluate the efficacy of a single dose of intraoperative methadone in reducing post-operative pain and opioid consumption in adolescents undergoing posterior spinal fusion. Our secondary goal is to determine the pharmacokinetics of IV methadone in children (0.3 and 0.4 mg/kg).

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Detailed Description

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Randomized, controlled, modified dose-escalation design. Patients receive standard monitoring for anesthesia and postoperative care. Surgical and anesthesia (except for opioid use) care are not altered for study purposes. All patients are induced by propofol and muscle relaxants. In the first cohort (n=30 evaluable), subjects are randomized 1:2 to either control (standard intraop opioid at anesthesiologists' discretion) or methadone HCl (0.4 mg/kg ideal body weight, IBW). In the second cohort (n=30 evaluable), subjects are randomized 1:2 to either control (standard intraop opioid) or methadone HCl (0.3 mg/kg ideal body weight, IBW). Subjects in the study groups will receive methadone (IV bolus, after induction of anesthesia) as their primary intraoperative opioid, rather than leaving the choice of intraoperative opioid to the anesthesiologist. Intraoperative breakthrough pain will be treated at the discretion of the anesthesiologist with fentanyl. In the control groups, intraoperative opioid administration will be left at the discretion of the anesthesia providers. Patient controlled analgesia as prescribed by the clinical team, using hydromorphone or morphine, will be used to treat postoperative pain relief.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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methadone HCl 0.3 mg/kg

0.3mg/kg IV methadone HCl

Group Type EXPERIMENTAL

0.3mg/kg IV methadone HCl

Intervention Type DRUG

Group I will receive 0.3mg/kg IV methadone HCl

methadone HCl 0.4 mg/kg

0.4mg/kg IV methadon HCl

Group Type EXPERIMENTAL

0.4mg/kg IV methadon HCl

Intervention Type DRUG

Group II will receive 0.4mg/kg IV methadone HCl.

control group

control no methadone, standard of care opioids.

Group Type ACTIVE_COMPARATOR

control no methadone

Intervention Type OTHER

The control group will not receive methadone.

Interventions

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0.3mg/kg IV methadone HCl

Group I will receive 0.3mg/kg IV methadone HCl

Intervention Type DRUG

0.4mg/kg IV methadon HCl

Group II will receive 0.4mg/kg IV methadone HCl.

Intervention Type DRUG

control no methadone

The control group will not receive methadone.

Intervention Type OTHER

Other Intervention Names

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methadone HCl, dolophine methadone HCl, dolophine

Eligibility Criteria

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Inclusion Criteria

* Age 11-18 years
* Undergoing general anesthesia and idiopathic posterior spinal surgery with anticipated postop inpatient stay of \> 3 days
* Signed, written, informed consent from legal guardians and assent from patient

Exclusion Criteria

* History of or known liver or kidney disease.
* Females who are pregnant or nursing.
* Children with developmental delay
* Children undergoing surgery for scoliosis of musculoskeletal origin

Minimum Eligible Age

11 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No