Clinical trial NCT02558010: Perioperative Methadone Use to Decrease Opioid Requirement in Pediatric Spinal Fusion Patients
Official title: Perioperative Methadone Use to Decrease Opioid Requirement in Pediatric Spinal Fusion Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Scoliosis
Pain
Keywords: Methadone
Gabapentin
Postoperative Pain
Posterior Spinal Fusion
Pediatric
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2015-09-23
Enrollment: 58
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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 use disorder
* Morphine, hydromorphone or methadone allergies
* Pregnancy
* Seizure disorders
* Bleeding disorders
* Neuromuscular scoliosis
* History of renal or hepatic disease
* Long QT syndrome
* Obstructive sleep apnea
* Body mass index \> 40
* Inability to tolerate standard analgesic medications (gabapentin, ketorolac, acetaminophen)
* Non-English speaking

Primary outcomes:
measure: Post-operative Opioid Consumption (mg/kg)
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Children's Wisconsin
state: Wisconsin
Study officials:
affiliation: Children's Hospital and Health System Foundation, Wisconsin
name: Steven Weisman, MD
role: STUDY_CHAIR
affiliation: Children's Hospital and Health System Foundation, Wisconsin
name: Roger A Fons, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berde CB, Beyer JE, Bournaki MC, Levin CR, Sethna NF. Comparison of morphine and methadone for prevention of postoperative pain in 3- to 7-year-old children. J Pediatr. 1991 Jul;119(1 Pt 1):136-41. doi: 10.1016/s0022-3476(05)81054-6.
citation: Gottschalk A, Durieux ME, Nemergut EC. Intraoperative methadone improves postoperative pain control in patients undergoing complex spine surgery. Anesth Analg. 2011 Jan;112(1):218-23. doi: 10.1213/ANE.0b013e3181d8a095. Epub 2010 Apr 24.
citation: Rusy LM, Hainsworth KR, Nelson TJ, Czarnecki ML, Tassone JC, Thometz JG, Lyon RM, Berens RJ, Weisman SJ. Gabapentin use in pediatric spinal fusion patients: a randomized, double-blind, controlled trial. Anesth Analg. 2010 May 1;110(5):1393-8. doi: 10.1213/ANE.0b013e3181d41dc2.
citation: Sharma A, Tallchief D, Blood J, Kim T, London A, Kharasch ED. Perioperative pharmacokinetics of methadone in adolescents. Anesthesiology. 2011 Dec;115(6):1153-61. doi: 10.1097/ALN.0b013e318238fec5.