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Methadone in Pediatric Anesthesiology II (MEPA II)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01990573
First received: November 7, 2013
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

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).


Condition Intervention
Pain
Drug: Group 1- 0.4mg/kg IV methadone HCl
Drug: Group 2 - 0.5mg/kg IV methadon HCI
Other: Group 3 - control no methadone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Methadone in Pediatric Anesthesia II

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Morphine consumption [ Time Frame: 4 days ] [ Designated as safety issue: No ]
    Measure of overall morphine consumption- morphine administration intra-operatively.

  • Pain scores [ Time Frame: 6 days ] [ Designated as safety issue: No ]
    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 Wong-Baker FACES scale employed by the inpatient nursing staff and previously validated (9). Pain relief is also assessed using a Colored-Visual Analog Scale. Sedation is assessed using a five-point scale (patient fully alert - not arousable). Itching and nausea are assessed using a five-point verbal scale (none, mild, moderate, severe or excruciating).


Secondary Outcome Measures:
  • Methadone clearance [ Time Frame: 96 hours ] [ Designated as safety issue: No ]
    blood draws up to 96 hours.


Estimated Enrollment: 60
Study Start Date: June 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1-methadone HC1 0.4 mg/kg
Patients in the Methadone HC1 0.4 arm will be randomized 1:2 to methadone HC1 0.4 mg/kg ideal body weight (IBW) or to the control group. Patients will receive Methadone HC1 at 0.4 mg/kg IBW as their intraoperative opioids or if in the control group they will receive intraoperative opioids at the discretion of their anesthesiologist.
Drug: Group 1- 0.4mg/kg IV methadone HCl
Group I will receive 0.4mg/kg IV methadone HCl
Other Name: methadone HCl, dolophine
Experimental: Group 2- methadone HC1 0.5 mg/kg
Patients in the Methadone HC1 0.5 arm will be randomized 1:2 to methadone HC1 0.5 mg/kg ideal body weight or to the control group. Patients will receive Methadone HC1 at .04 mg/kg IBW as their intraoperative opioids or if in the control group they will receive intraoperative opioids at the discretion of their anesthesiologist.
Drug: Group 2 - 0.5mg/kg IV methadon HCI
Group II will receive 0.5mg/kg IV methadone HCl.
Other Name: methadone HCl, dolophine
Active Comparator: Group 3- control group
Group III will be the control group and will not receive any methadone.
Other: Group 3 - control no methadone
The control group will not receive methadone.

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

Ages Eligible for Study:   11 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01990573

Locations
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Jane Blood, RN    314-757-5531    bloodj@anest.wustl.edu   
Principal Investigator: Anshuman Sharma, MD         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Anshuman Sharma, MD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01990573     History of Changes
Other Study ID Numbers: 201302099
Study First Received: November 7, 2013
Last Updated: July 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Washington University School of Medicine:
spinal surgery
Methadone

Additional relevant MeSH terms:
Methadone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Antitussive Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on August 26, 2014