Perioperative Methadone Use to Decrease Opioid Requirement in Pediatric Spinal Fusion Patients

Sponsor

Medical College of Wisconsin (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02558010

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Acute pain management following major surgical procedures in pediatric patients continues to be a challenge, especially after extensive posterior spine fusions.

Spine surgery is particularly traumatic, initiating pain in both peripheral and central pathways. While the standard management of post-surgical pain involves a multimodal approach, opioids provide the predominant benefit. However, opioid use is associated with many adverse effects, including nausea, constipation, and pruritus. Perioperative methadone may decrease total opioid consumption and adverse effects as well as improve satisfaction with pain management after scoliosis repair.

Condition or Disease	Intervention/Treatment	Phase
Scoliosis Pain	Drug: Methadone Other: Normal Saline Drug: Morphine	Phase 3

Detailed Description

This study is a double blind comparison, evaluating the benefits of intraoperative methadone in extensive posterior spine fusion surgery for idiopathic scoliosis. Methadone 0.2 mg/kg will be given to the treatment group. Postoperative evaluation for narcotic use, pain control, and adverse effects will be compared to a standard treatment approach used at Children's Hospital of Wisconsin.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Perioperative Methadone Use to Decrease Opioid Requirement in Pediatric Spinal Fusion Patients

Actual Study Start Date :

May 1, 2016

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Methadone Group Patients will receive a total of 0.2mg/kg IV methadone intraoperative (0.1mg / kg preincision and 0.1mg/kg prior to emergence) with a maximum dosing of 20 mg.	Drug: Methadone Perioperative IV methadone to be given Other Names: generic methadone Drug: Morphine Both groups will receive morphine via Patient-Controlled Analgesia (PCA) pump. Other Names: Duramorph
Active Comparator: Control Group Patient will receive normal saline placebo initially, then morphine prior to emergence.	Other: Normal Saline control arm Other Names: salt water Drug: Morphine Both groups will receive morphine via Patient-Controlled Analgesia (PCA) pump. Other Names: Duramorph

Arm

Intervention/Treatment

Experimental: Methadone Group

Patients will receive a total of 0.2mg/kg IV methadone intraoperative (0.1mg / kg preincision and 0.1mg/kg prior to emergence) with a maximum dosing of 20 mg.

Drug: Methadone

Perioperative IV methadone to be given

Other Names:

generic methadone

Drug: Morphine

Both groups will receive morphine via Patient-Controlled Analgesia (PCA) pump.

Other Names:

Duramorph

Active Comparator: Control Group

Patient will receive normal saline placebo initially, then morphine prior to emergence.

Other: Normal Saline

control arm

Other Names:

salt water

Drug: Morphine

Both groups will receive morphine via Patient-Controlled Analgesia (PCA) pump.

Other Names:

Duramorph

Outcome Measures

Primary Outcome Measures

Post-operative Pain Score on the verbal numeric pain scale [72 hours]
Scores range from 0 (no pain) - 10 (worst possible pain)

Secondary Outcome Measures

Itching as assessed by number of doses of benadryl required post-operatively [72 Hours]
Number of doses benadryl per patient over 3 post-op days
Patient satisfaction as assessed by the question "How satisfied were you with your pain management?" [72 hours]
Responses can range from 0 (very dissatisfied) to 10 (very satisfied)
Nausea as assessed by number of doses of ondansetron required post-operatively [72 hours]
Number of doses ondansetron per patient over 3 post-op days
Constipation as assessed by number of days to first bowel movement [72 hours]
Number of days to first bowel movement will be recorded for each patient

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 10-18 years
Idiopathic scoliosis
Fusion levels planned for 10 or greater
English speaking
American Society of Anesthesiology (ASA) class 1 - 3

Exclusion Criteria:

Current narcotic use / History of substance abuse
Morphine, hydromorphone or methadone allergies
Pregnancy
Seizure Disorders
Bleeding disorders
Neuromuscular scoliosis
Non-English speaking

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Wisconsin	Milwaukee	Wisconsin	United States	53201

Sponsors and Collaborators

Medical College of Wisconsin

Investigators

Study Chair: Steven Weisman, MD, Children's Hospital and Health System Foundation, Wisconsin
Principal Investigator: Roger A Fons, MD, Children's Hospital and Health System Foundation, Wisconsin