NCT00955877

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

Terminated NA Results posted Last updated 13 June 2018

What this trial tests

NA trial testing Extended-release Epidural morphine (EREM) 80 in Spastic Cerebral Palsy in 13 participants. Terminated before completion.

Timeline

1 March 2010

Primary endpoint
1 January 2015

1 January 2015

Quick facts

Lead sponsor	Washington University School of Medicine
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	13
Start date	1 March 2010
Primary completion	1 January 2015
Estimated completion	1 January 2015
Sites	1 location across United States

Drugs / interventions tested

• Extended-release Epidural morphine (EREM) 80 — full drug profile →
• Extended-release Epidural Morphine (EREM) 120 — full drug profile →
• Control: Saline

Conditions studied

• Spastic Cerebral Palsy — all drugs for Spastic Cerebral Palsy →

Sponsor

Washington University School of Medicine

Who can join

Adults 2 to 12, any sex, with Spastic Cerebral Palsy. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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 participa
• 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.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.