Extended-release Epidural Morphine for Acute Post-operative Analgesia Following Selective Dorsal Rhizotomy in Children

June 13, 2018 updated by: Washington University School of Medicine

Randomized, Double-Blinded Placebo Controlled Trial of Epidural, Sustained-relief Morphine for Acute Post-operative Analgesia Following Selective Dorsal Rhizotomy in Children

The purpose of this proposal is to improve the investigators' current Selective Dorsal Rhizotomy (SDR) analgesia protocol by eliminating or minimizing the use of fentanyl in the post-operative period.

Children undergoing SDR for spastic cerebral palsy have significant post-operative pain. The procedure requires dissection of the lumbar back musculature and removal of the L1 lamina (the bony posterior part of the vertebra). The majority of the operation is intradural, and a water-tight dural closure at the termination of the operation is critical in order to prevent leakage of cerebrospinal fluid (CSF) from the wound. In fact, these children must remain flat on their back for 48 hours to allow the dural incision to heal prior to mobilization. Thus, adequate pain control is essential not only for patient comfort, but also to prevent agitation and additional stress on the dural closure.

Currently, the investigators' patients undergoing SDR are treated for 48 hours with scheduled intravenous (IV) narcotic (continuous fentanyl infusion at 0.5-2.0 μg/kg/hour) in addition to the sedative/muscle relaxant Valium (0.2 mg/kg IV every 4 hours for 24 hours, then every 6 hours for 24 hours). The IV fentanyl, and to a lesser degree Valium, carries a real risk of hypotension and respiratory depression and requires frequent dose adjustments to achieve adequate analgesia.

By improving the current SDR analgesia protocol, the investigators hope to maximize patient safety and comfort while maintaining the effectiveness of the operation by minimizing the risk of CSF leak.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

improve the investigators' current Selective Dorsal Rhizotomy (SDR) analgesia protocol by eliminating or minimizing the use of fentanyl in the post-operative period.

Children undergoing SDR for spastic cerebral palsy have significant post-operative pain. The procedure requires dissection of the lumbar back musculature and removal of the L1 lamina (the bony posterior part of the vertebra). The majority of the operation is intradural, and a water-tight dural closure at the termination of the operation is critical in order to prevent leakage of cerebrospinal fluid (CSF) from the wound. In fact, these children must remain flat on their back for 48 hours to allow the dural incision to heal prior to mobilization. Thus, adequate pain control is essential not only for patient comfort, but also to prevent agitation and additional stress on the dural closure.

Currently, the investigators' patients undergoing SDR are treated for 48 hours with scheduled intravenous (IV) narcotic (continuous fentanyl infusion at 0.5-2.0 μg/kg/hour) in addition to the sedative/muscle relaxant Valium (0.2 mg/kg IV every 4 hours for 24 hours, then every 6 hours for 24 hours). The IV fentanyl, and to a lesser degree Valium, carries a real risk of hypotension and respiratory depression and requires frequent dose adjustments to achieve adequate analgesia.

By improving the current SDR analgesia protocol, the investigators hope to maximize patient safety and comfort while maintaining the effectiveness of the operation by minimizing the risk of CSF leak.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • St. Louis Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Receiving selective dorsal rhizotomy (SDR)
  • Willingness to Participate

Exclusion Criteria:

  • Known Morphine Allergy
  • Inability to speak and read the English language

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DepoDur80
DepoDur will be administered at 80μg/kg (not to exceed 5 mg total/patient) under direct vision in the L1 laminectomy defect prior to wound closure.
Drug: Extended-release Epidural morphine (EREM) 80
After completion of the rhizotomy, the dura will be closed in the standard water-tight fashion with running suture. Epidural DepoDur (80μg/kg) will be placed under direct vision in the L1 laminectomy defect. It will also be dispensed 1-2 levels above and 1-2 levels below using a flexible angiocatheter.
Other Names:
  • DepoDur
Experimental: DepoDur120
DepoDur will be administered at 120μg/kg (not to exceed 10 mg total/patient) under direct vision in the L1 laminectomy defect prior to wound closure.
Drug: Extended-release Epidural Morphine (EREM) 120
After completion of the rhizotomy, the dura will be closed in the standard water-tight fashion with running suture. Epidural DepoDur (120μg/kg) will be placed under direct vision in the L1 laminectomy defect. It will also be dispensed 1-2 levels above and 1-2 levels below using a flexible angiocatheter.
Other Names:
  • DepoDur
Placebo Comparator: Control
Preservative-free normal saline (2.5ml) will be placed in the L1 laminectomy defect and also dispensed 1-2 levels above and 1-2 levels below using a flexible angiocatheter prior to wound closure.
Drug: Control: Saline
After completion of the rhizotomy, the dura will be closed in the standard water-tight fashion with running suture. Preservative-free normal saline (2.5 ml) will be placed under direct vision in the L1 laminectomy defect. It will also be dispensed 1-2 levels above and 1-2 levels below using a flexible angiocatheter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adequacy of Analgesia as Judged by Age-adjusted Pain Scales
Time Frame: 48 hour post-operative period
Mean and standard deviation for standardized, age-appropriate pain scales (per patient per day) 48hrs post surgery. As is standard of care at St. Louis Children's Hospital, pain level was scored based on age using the "Face, Legs, Activity, Cry, Consolability" (FLACC) for participants aged 0-3, the FACES scale on participants between the age of 3 and 5, numeric pain rating scale (NRS) on participants between the age of 5 and 8 years, or the Individualized Numeric Rating Scale (INRS) for participants greater than or equal to 8 years of age. All four of the scales were ranged from 0-10 scores, with 0 being no pain at all, and 10 being extreme pain. Each patient had two scores given, one at 24hrs and one at 48hrs post surgery. The output was reported as an average of all scores for all patients within each group.
48 hour post-operative period
Quantity of Fentanyl Administered
Time Frame: 48 hour post-operative period
Mean and standard deviation of total quantity of fentanyl administered (per patient per day) 48hrs post surgery.
48 hour post-operative period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Respiratory Depression Within 48hrs Post op
Time Frame: 48 hour post-operative period
Number of participants with respiratory depression within 48hrs post operation
48 hour post-operative period
Number of Participants With Hemodynamic Instability 48hrs Post op
Time Frame: 48 hour post-operative period
Number of Participants with Hemodynamic Instability 48hrs post operation
48 hour post-operative period
Number of Participants With CSF Leaks Within 6 Months Post op.
Time Frame: 6 month post-operative period
Number of participants with CSF leaks within 6 months post operation.
6 month post-operative period
Number of Participants That Had Urine Retention for 48hrs Post Foley Catheter Removal.
Time Frame: After the Foley catheter has been removed on post-operative day #1 for a 48 hour follow-up period
Number of participants that had urine retention for 48hrs post foley catheter removal.
After the Foley catheter has been removed on post-operative day #1 for a 48 hour follow-up period
Number of Participants With Nausea and/or Vomiting 48hrs Post op.
Time Frame: 48 hour post-operative period
Number of participants with nausea and or vomiting 48hr post surgery
48 hour post-operative period
Number of Participants With Pruritis Within 48hrs Post op
Time Frame: 48 hour post-operative period
Number of participants with pruritis within 48hrs post operation
48 hour post-operative period
Number of Participants That Were Given Codeine 48hr Post Surgery
Time Frame: 48hr post surgery
Number of participants that were given codeine 48hr post surgery
48hr post surgery
Number of Participants That Were Given Zofran 48hr Post Surgery
Time Frame: 48hr post surgery
Number of participants that were given Zofran 48hr post surgery
48hr post surgery
Number of Participants That Were Bradycardia Within 48hr Post Surgery
Time Frame: 48hr post surgery
Number of participants that were bradycardia within 48hr post surgery
48hr post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: David Limbrick, M.D., Ph.D., Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

August 3, 2009

First Submitted That Met QC Criteria

August 7, 2009

First Posted (Estimate)

August 10, 2009

Study Record Updates

Last Update Posted (Actual)

July 11, 2018

Last Update Submitted That Met QC Criteria

June 13, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DeporDur2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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