Methadone in Pediatric Anesthesiology II

Pain Clinical Trial

— MEPAII  

Official title:

Methadone in Pediatric Anesthesia II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01990573
• Other study ID #: 201302099
• Status: Completed
• Phase: N/A
• Start date: April 10, 2013
• Est. completion date: June 30, 2018

Study information

• Verified date: January 2020
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 (0.3 and 0.4 mg/kg).

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 (0.3 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• 0.3mg/kg IV methadone HCl
Group I will receive 0.3mg/kg IV methadone HCl
• 0.4mg/kg IV methadon HCl
Group II will receive 0.4mg/kg IV methadone HCl.

Other:
• control no methadone
The control group will not receive methadone.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Opioid Consumption (Morphine Equivalent)	Measure of overall morphine consumption	6 days
Primary	Pain Scores	Assessments are made in the postoperative period by a trained member of the research team blinded to intraoperative use of methadone. These will be conducted on each post-operative day until discharge or post op day 6, whichever comes first. Pain intensity is assessed using the numeric pain score (0-10) scale employed by the inpatient nursing staff and previously validated .	6 days
Secondary	Cmax of R and S Methadone	Cmax is the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated and before the administration of a second dose.	96 hours