Methadone in Pediatric Anesthesiology II
Information source: Washington University School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: Group 1- 0.4mg/kg IV methadone HCl (Drug); Group 2 - 0.5mg/kg IV methadon HCI (Drug); Group 3 - control no methadone (Other)
Phase: N/A
Status: Recruiting
Sponsored by: Washington University School of Medicine Official(s) and/or principal investigator(s): Anshuman Sharma, MD, Principal Investigator, Affiliation: Washington University School of Medicine
Summary
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. 4 and 0. 5 mg/kg).
Clinical Details
Official title: Methadone in Pediatric Anesthesia II
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Morphine consumptionPain scores
Secondary outcome: Methadone clearance
Detailed description:
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. 5 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.
Eligibility
Minimum age: 11 Years.
Maximum age: 18 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Washington University School of Medicine, St. Louis, Missouri 63110, United States; Recruiting Jane Blood, RN, Phone: 314-757-5531, Email: bloodj@anest.wustl.edu Anshuman Sharma, MD, Principal Investigator
Additional Information
Starting date: June 2013
Last updated: August 13, 2015
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