A Trial Comparing Single Intra-op Dose of Methadone Versus Placebo in Patients Undergoing Spine Surgery
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|ClinicalTrials.gov Identifier: NCT02206685|
Recruitment Status : Completed
First Posted : August 1, 2014
Last Update Posted : January 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Thoracolumbar Scoliosis||Drug: Methadone Drug: Normal Saline||Phase 4|
Scoliosis is a disease that involves lateral and/or rotational deformity of the spine and can affect up to 4% of the population. Typically, surgery is considered when Cobb's angle, which is a measurement used for evaluation of curves in scoliosis on an anterior-posterior radiographic projection of the spine, is greater than 50 degrees in the thoracic region (40 degrees in the lumbar region) or when the curvature causes significant pain, or respiratory and cardiovascular restriction. Patient undergoing this surgical correction experience severe pain in the postoperative period and the management includes the use of opioid-based patient-controlled analgesia (PCA).
Methadone is an opioid with one of the longest elimination half-life and has been used as an effective analgesic for acute, chronic, neuropathic, and cancer pain in adults, children, and even neonates1-5. Its long duration of action and antagonism to the N-methyl-d-aspartate receptor may decrease the need for PCA use in the postoperative period. Gourlay2 demonstrated the effectiveness and utility of perioperative methadone including the advantages of longer analgesia with no serious side effects of respiratory depression. A recent study by Gottschalk2 in adult patients demonstrated a 50% reduction of postoperative opioids at 48 hours and lower pain scores after a single bolus of methadone before surgical incision. However, a major weakness of the study is that patients did not receive equipotent intraoperative opioids. In addition, the adolescent patient population will undergo a much larger surgical incision with potential for greater postoperative pain. Despite this potential benefit, methadone is seldom used in the perioperative setting. A more recent pharmacokinetic study of methadone in adolescents undergoing spine surgery failed to show a reduction in opioid consumption as it was powered to determine pharmacokinetics and not a secondary endpoint of postoperative opioid consumption. An appropriately powered study is still required to determine the efficacy of methadone in reducing postoperative pain after spine surgery.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||A Randomized Blinded Prospective Trial Comparing Single Intraoperative Dose of Methadone Versus Placebo in Pediatric Patients Undergoing Spine Surgery.|
|Actual Study Start Date :||May 2014|
|Actual Primary Completion Date :||January 27, 2020|
|Actual Study Completion Date :||January 27, 2020|
Active Comparator: Treatment group
The treatment group will receive 0.2 mg/kg methadone diluted to a 20 ml infusion over 10 minutes.
The treatment group will receive 0.2 mg/kg methadone diluted to a 20 ml infusion over 10 minutes
Other Name: Treatment group
Placebo Comparator: Control Group
The control group will receive a 20 ml normal saline placebo infusion over 10 minutes
Drug: Normal Saline
the control group will receive a 20 ml normal saline placebo infusion over 10 minutes
Other Name: Control Group
- Opioid Usage [ Time Frame: 5 days post op ]The primary endpoints is the total opioid usage during POD (postoperative day) 0-4.
- Pain Scores [ Time Frame: 5 days ]Secondary endpoints include and pain scores during rest and with activity (getting out bed and ambulation) on POD 0-5 and side effects of pain medications
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02206685
|United States, Texas|
|Texas Children't Hospital|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Kim Nguyen, MD||Baylor College of Medicine|