Spastic Cerebral PalsyNCT00955877
Extended-release Epidural Morphine for Acute Post-operative Analgesia Following Selective Dorsal Rhizotomy in Children
A study testing Extended-release Epidural morphine (EREM) 80 and Extended-release Epidural Morphine (EREM) 120 in people with Spastic Cerebral Palsy, run by Washington University School of Medicine at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Spastic Cerebral Palsy
- What is being tested?
- Extended-release Epidural morphine (EREM) 80 and Extended-release Epidural Morphine (EREM) 120
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Jan 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Receiving selective dorsal rhizotomy (SDR)
- Willingness to Participate
Who cannot join
- Known Morphine Allergy
- Inability to speak and read the English language
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Louis Children's Hospital
St Louis, Missouri, 63110
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Spastic Cerebral Palsy
- Being tested
- Extended-release Epidural morphine (EREM) 80, Extended-release Epidural Morphine (EREM) 120, Control: Saline
- Keywords
- extended-release epidural morphine, DepoDur, Spastic Cerebral Palsy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended-release Epidural morphine (EREM) 80Drug
Also called DepoDur
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.
Extended-release Epidural Morphine (EREM) 120Drug
Also called DepoDur
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.
Control: SalineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| DepoDur80 | Experimental | 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. Receives: Drug: Extended-release Epidural morphine (EREM) 80 |
| DepoDur120 | Experimental | 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. Receives: Drug: Extended-release Epidural Morphine (EREM) 120 |
| Control | Placebo comparator | 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. Receives: Drug: Control: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequacy of Analgesia as Judged by Age-adjusted Pain Scales
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.
Measured: 48 hour post-operative period
Quantity of Fentanyl Administered
Mean and standard deviation of total quantity of fentanyl administered (per patient per day) 48hrs post surgery.
Measured: 48 hour post-operative period
Secondary outcomes (9)
Number of Participants With Respiratory Depression Within 48hrs Post op
Number of participants with respiratory depression within 48hrs post operation
Measured: 48 hour post-operative period
Number of Participants With Hemodynamic Instability 48hrs Post op
Number of Participants with Hemodynamic Instability 48hrs post operation
Measured: 48 hour post-operative period
Number of Participants With CSF Leaks Within 6 Months Post op.
Number of participants with CSF leaks within 6 months post operation.
Measured: 6 month post-operative period
Number of Participants That Had Urine Retention for 48hrs Post Foley Catheter Removal.
Number of participants that had urine retention for 48hrs post foley catheter removal.
Measured: 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.
Number of participants with nausea and or vomiting 48hr post surgery
Measured: 48 hour post-operative period
Number of Participants With Pruritis Within 48hrs Post op
Number of participants with pruritis within 48hrs post operation
Measured: 48 hour post-operative period
Number of Participants That Were Given Codeine 48hr Post Surgery
Number of participants that were given codeine 48hr post surgery
Measured: 48hr post surgery
Number of Participants That Were Given Zofran 48hr Post Surgery
Number of participants that were given Zofran 48hr post surgery
Measured: 48hr post surgery
Number of Participants That Were Bradycardia Within 48hr Post Surgery
Number of participants that were bradycardia within 48hr post surgery
Measured: 48hr post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2009 (estimated)
- Study startMar 2010
- Primary completionJan 2015
- Study completionJan 2015
Why it stopped: The manufacturer decided to stop drug production.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Spastic Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Limbrick, M.D., Ph.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00955877
- Sponsor's protocol ID
- DeporDur2009
- Status last verified
- Jun 2018
- First submitted
- 3 Aug 2009
- Last updated
- 11 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Clark SL, Hankins GD. Temporal and demographic trends in cerebral palsy--fact and fiction. Am J Obstet Gynecol. 2003 Mar;188(3):628-33. doi: 10.1067/mob.2003.204.
PubMed 12634632Kuban KC, Leviton A. Cerebral palsy. N Engl J Med. 1994 Jan 20;330(3):188-95. doi: 10.1056/NEJM199401203300308. No abstract available.
PubMed 8264743Grether JK, Cummins SK, Nelson KB. The California Cerebral Palsy Project. Paediatr Perinat Epidemiol. 1992 Jul;6(3):339-51. doi: 10.1111/j.1365-3016.1992.tb00774.x.
PubMed 1635884Taft LT. Cerebral palsy. Pediatr Rev. 1995 Nov;16(11):411-8; quiz 418. No abstract available.
PubMed 8539191Steinbok P. Outcomes after selective dorsal rhizotomy for spastic cerebral palsy. Childs Nerv Syst. 2001 Jan;17(1-2):1-18. doi: 10.1007/pl00013722.
PubMed 11219613McLaughlin J, Bjornson K, Temkin N, Steinbok P, Wright V, Reiner A, Roberts T, Drake J, O'Donnell M, Rosenbaum P, Barber J, Ferrel A. Selective dorsal rhizotomy: meta-analysis of three randomized controlled trials. Dev Med Child Neurol. 2002 Jan;44(1):17-25. doi: 10.1017/s0012162201001608.
PubMed 11811645Wright FV, Sheil EM, Drake JM, Wedge JH, Naumann S. Evaluation of selective dorsal rhizotomy for the reduction of spasticity in cerebral palsy: a randomized controlled tria. Dev Med Child Neurol. 1998 Apr;40(4):239-47. doi: 10.1111/j.1469-8749.1998.tb15456.x.
PubMed 9593495Steinbok P, Reiner AM, Beauchamp R, Armstrong RW, Cochrane DD, Kestle J. A randomized clinical trial to compare selective posterior rhizotomy plus physiotherapy with physiotherapy alone in children with spastic diplegic cerebral palsy. Dev Med Child Neurol. 1997 Mar;39(3):178-84. doi: 10.1111/j.1469-8749.1997.tb07407.x.
PubMed 9112967McLaughlin JF, Bjornson KF, Astley SJ, Graubert C, Hays RM, Roberts TS, Price R, Temkin N. Selective dorsal rhizotomy: efficacy and safety in an investigator-masked randomized clinical trial. Dev Med Child Neurol. 1998 Apr;40(4):220-32. doi: 10.1111/j.1469-8749.1998.tb15454.x.
PubMed 9593493Chicoine MR, Park TS, Kaufman BA. Selective dorsal rhizotomy and rates of orthopedic surgery in children with spastic cerebral palsy. J Neurosurg. 1997 Jan;86(1):34-9. doi: 10.3171/jns.1997.86.1.0034.
PubMed 8988079Park TS, Johnston JM. Surgical techniques of selective dorsal rhizotomy for spastic cerebral palsy. Technical note. Neurosurg Focus. 2006 Aug 15;21(2):e7.
PubMed 16918228Hartrick CT, Hartrick KA. Extended-release epidural morphine (DepoDur): review and safety analysis. Expert Rev Neurother. 2008 Nov;8(11):1641-8. doi: 10.1586/14737175.8.11.1641.
PubMed 18986234Gambling D, Hughes T, Martin G, Horton W, Manvelian G; Single-Dose EREM Study Group. A comparison of Depodur, a novel, single-dose extended-release epidural morphine, with standard epidural morphine for pain relief after lower abdominal surgery. Anesth Analg. 2005 Apr;100(4):1065-1074. doi: 10.1213/01.ANE.0000145009.03574.78.
PubMed 15781524Carvalho B, Riley E, Cohen SE, Gambling D, Palmer C, Huffnagle HJ, Polley L, Muir H, Segal S, Lihou C, Manvelian G; DepoDur Study Group. Single-dose, sustained-release epidural morphine in the management of postoperative pain after elective cesarean delivery: results of a multicenter randomized controlled study. Anesth Analg. 2005 Apr;100(4):1150-1158. doi: 10.1213/01.ANE.0000149544.58230.FF.
PubMed 15781537Carvalho B, Roland LM, Chu LF, Campitelli VA 3rd, Riley ET. Single-dose, extended-release epidural morphine (DepoDur) compared to conventional epidural morphine for post-cesarean pain. Anesth Analg. 2007 Jul;105(1):176-83. doi: 10.1213/01.ane.0000265533.13477.26.
PubMed 17578973
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blinded Placebo Controlled Trial of Epidural, Sustained-relief Morphine for Acute Post-operative Analgesia Following Selective Dorsal Rhizotomy in Children
- ClinicalTrials.gov ID
- NCT00955877
- Acronym / sponsor ID
- DeporDur2009
- Conditions
- Spastic Cerebral Palsy
- Keywords
- extended-release epidural morphine, DepoDur, Spastic Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The manufacturer decided to stop drug production.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 10 Aug 2009 (estimated)
- Results
- Posted 13 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DepoDur80 | Experimental | Drug: Extended-release Epidural morphine (EREM) 80DepoDur 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. |
| DepoDur120 | Experimental | Drug: Extended-release Epidural Morphine (EREM) 120DepoDur 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. |
| Control | Placebo comparator | Drug: Control: SalinePreservative-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. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Receiving selective dorsal rhizotomy (SDR)
- Willingness to Participate
Key exclusion criteria (2 listed)
- Known Morphine Allergy
- Inability to speak and read the English language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extended-release Epidural morphine (EREM) 80Also: DepoDurAfter 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. | Drug | DepoDur80 |
| Extended-release Epidural Morphine (EREM) 120Also: DepoDurAfter 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. | Drug | DepoDur120 |
| Control: SalineAfter 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. | Drug | Control |
Primary outcome
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.
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.
9 secondary outcomes
Number of Participants With Respiratory Depression Within 48hrs Post op
Time frame: 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 CSF Leaks Within 6 Months Post op.
Time frame: 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 With Nausea and/or Vomiting 48hrs Post op.
Time frame: 48 hour post-operative period
Number of Participants With Pruritis Within 48hrs Post op
Time frame: 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 Zofran 48hr Post Surgery
Time frame: 48hr post surgery
Number of Participants That Were Bradycardia Within 48hr Post Surgery
Time frame: 48hr post surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12634632Clark SL, Hankins GD. Temporal and demographic trends in cerebral palsy--fact and fiction. Am J Obstet Gynecol. 2003 Mar;188(3):628-33. doi: 10.1067/mob.2003.204.
- Background: PubMed 8264743Kuban KC, Leviton A. Cerebral palsy. N Engl J Med. 1994 Jan 20;330(3):188-95. doi: 10.1056/NEJM199401203300308. No abstract available.
- Background: PubMed 1635884Grether JK, Cummins SK, Nelson KB. The California Cerebral Palsy Project. Paediatr Perinat Epidemiol. 1992 Jul;6(3):339-51. doi: 10.1111/j.1365-3016.1992.tb00774.x.
- Background: PubMed 8539191Taft LT. Cerebral palsy. Pediatr Rev. 1995 Nov;16(11):411-8; quiz 418. No abstract available.
- Background: PubMed 11219613Steinbok P. Outcomes after selective dorsal rhizotomy for spastic cerebral palsy. Childs Nerv Syst. 2001 Jan;17(1-2):1-18. doi: 10.1007/pl00013722.
- Background: PubMed 11811645McLaughlin J, Bjornson K, Temkin N, Steinbok P, Wright V, Reiner A, Roberts T, Drake J, O'Donnell M, Rosenbaum P, Barber J, Ferrel A. Selective dorsal rhizotomy: meta-analysis of three randomized controlled trials. Dev Med Child Neurol. 2002 Jan;44(1):17-25. doi: 10.1017/s0012162201001608.
- Background: PubMed 9593495Wright FV, Sheil EM, Drake JM, Wedge JH, Naumann S. Evaluation of selective dorsal rhizotomy for the reduction of spasticity in cerebral palsy: a randomized controlled tria. Dev Med Child Neurol. 1998 Apr;40(4):239-47. doi: 10.1111/j.1469-8749.1998.tb15456.x.
- Background: PubMed 9112967Steinbok P, Reiner AM, Beauchamp R, Armstrong RW, Cochrane DD, Kestle J. A randomized clinical trial to compare selective posterior rhizotomy plus physiotherapy with physiotherapy alone in children with spastic diplegic cerebral palsy. Dev Med Child Neurol. 1997 Mar;39(3):178-84. doi: 10.1111/j.1469-8749.1997.tb07407.x.
- Background: PubMed 9593493McLaughlin JF, Bjornson KF, Astley SJ, Graubert C, Hays RM, Roberts TS, Price R, Temkin N. Selective dorsal rhizotomy: efficacy and safety in an investigator-masked randomized clinical trial. Dev Med Child Neurol. 1998 Apr;40(4):220-32. doi: 10.1111/j.1469-8749.1998.tb15454.x.
- Background: PubMed 8988079Chicoine MR, Park TS, Kaufman BA. Selective dorsal rhizotomy and rates of orthopedic surgery in children with spastic cerebral palsy. J Neurosurg. 1997 Jan;86(1):34-9. doi: 10.3171/jns.1997.86.1.0034.
- Background: PubMed 16918228Park TS, Johnston JM. Surgical techniques of selective dorsal rhizotomy for spastic cerebral palsy. Technical note. Neurosurg Focus. 2006 Aug 15;21(2):e7.
- Background: PubMed 18986234Hartrick CT, Hartrick KA. Extended-release epidural morphine (DepoDur): review and safety analysis. Expert Rev Neurother. 2008 Nov;8(11):1641-8. doi: 10.1586/14737175.8.11.1641.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Limbrick, M.D., Ph.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extended-release Epidural morphine (EREM) 80 and Extended-release Epidural Morphine (EREM) 120 in people with Spastic Cerebral Palsy, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adequacy of Analgesia as Judged by Age-adjusted Pain Scales (time frame: 48 hour post-operative period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00955877, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2018.