Intrathecal Morphine Versus Epidural Extended Release Morphine for Pediatric Patients Undergoing Spinal Fusion

NCT00880607 | Completed Phase 4 Results DMC

• 2 other identifiers: 08-0721Seed grant UCHSC
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

This study plans to learn more about preventing pain in children who are having posterior spinal fusion surgery using two different kinds of morphine (a pain medicine). Also, this study plans to learn about individual differences in the how the different kinds of morphine work in children. Subjects are being asked to be in this research study because they are having spinal fusion surgery, will have pain some of the time and will be getting morphine during and after surgery to help control their pain.

Conditions

Pain Management; Spinal Fusion; Scoliosis

Keywords

Pain; Pediatric; Spinal Fusion; pain management

Outcome Measures

Primary Outcomes (1)

• Total IV Morphine Consumption up to 48 Hours Post Surgery

  Total IV morphine consumption during the first 0- 48 hours after surgery.Postoperative pain was treated with morphine PCA, ketorolac, oral oxycodone, and acetaminophen.

  Four hour intervals for up to 48 hours

Secondary Outcomes (6)

• Time Until First PCA Demand Request

  every 4 hours up to 48 hours

• Post-operative Pain Scores

  every 4 hours up to 48 hours

• Adverse Opioid Effect: Nausea

  every 4 hours up to 48 hours

• Adverse Opioid Effect: Emesis

  every 4 hours up to 48 hours

• Adverse Opioid Effect: Pruritus

  every 4 hours up to 48 hours

Study Arms (2)

Intrathecal morphine

ACTIVE COMPARATOR

Receives a single dose of intrathecal morphine

Drug: Intrathecal morphine

Extended Release Epidural Morphine

EXPERIMENTAL

Receives DepoDur extended release epidural morphine for pain management

Drug: Extended Release Epidural Morphine

Interventions

Intrathecal morphine DRUG

Morphine injection is a systemic narcotic analgesic for administration by the intravenous, epidural or intrathecal routes. It is used for the management of pain.

Also known as: IT Morphine

Intrathecal morphine

Extended Release Epidural Morphine DRUG

DepoDur™ is a preparation of extended release lipid encapsulated morphine and is used specifically for epidural injection, outside the spinal fluid, for postoperative pain. This study is a prospective randomized double-blinded trial examining the effectiveness of single dose intrathecal morphine versus single dose extended release epidural morphine for postoperative pain control in pediatric posterior spinal fusion patients.

Also known as: EREM, DepoDur

Extended Release Epidural Morphine

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male and females, 8 to17 years old undergoing posterior spinal fusion for idiopathic scoliosis.
• Fusion of a minimum of 5, and a maximum of 13 levels, including at least L1 or lower.

You may not qualify if:

• Neuromuscular scoliosis.
• A history of documented coagulopathy or platelet count of less than 100,000 mm3.
• A known allergy or adverse sensitivity to morphine.
• Pulmonary hypertension or other significant respiratory problem.
• Cognitive deficits that would impair use of PCA and/or filling out questionnaire.
• History of sleep apnea defined by sleep study and/or need for nighttime CPAP.
• Abnormal pain thresholds (i.e., subjects who are on significant opioids preoperatively).
• Baseline neurologic deficits (numbness, motor deficits, or any focal neurological sign).
• Subjects who are anticipated to remain intubated postoperatively for longer than 2 hours.
• Need for preoperative intravenous inotropic drugs.
• Significant metabolic, endocrine or neuropathology, cyanosis, or renal insufficiency.
• A contraindication to dural puncture, such as raised intracranial pressure.
• Pre-operative heparin, oral aspirin or anticoagulants.
• Weight less than 20kg or greater than 100kg.
• Need for Intraoperative ketamine administration.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

The Children's Hospital- Denver

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Agnosia; Scoliosis; Pain

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Results Point of Contact

• Title: Mindy Cohen, MD FAAP, Assistant Professor, Department of Anesthesiology
• Organization: Children's Hospital of Colorado, University of Colorado

Mindy.cohen@childrenscolorado.org

Study Officials

• Mindy Cohen, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2009
• First Posted: April 14, 2009
• Study Start: December 1, 2008
• Primary Completion: April 1, 2011
• Study Completion: September 1, 2012
• Last Updated: April 22, 2020
• Results First Posted: April 22, 2020

Record last verified: 2020-04

Locations

US (1)