Phase 4
Completed N=81
Intrathecal Morphine Versus Epidural Extended Release Morphine for Pediatric Patients Undergoing Spinal Fusion
Pain Management · Spinal Fusion · scoliosis
Source: ClinicalTrials.gov NCT00880607 ↗
Enrolled (actual)
81
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcomePrimary: Total IV Morphine Consumption up to 48 Hours Post Surgery — 34.0; 42.2 mg — p=.27
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total IV Morphine Consumption up to 48 Hours Post Surgery |
34.0; 42.2 | .27 |
| SECONDARY Time Until First PCA Demand Request |
0.99; 0.92 | .42 |
| SECONDARY Post-operative Pain Scores |
3.26; 6.69; 2.70; 4.03; 2.25; 2.88 | — |
| SECONDARY Adverse Opioid Effect: Nausea |
46; 26 | 0.08 |
| SECONDARY Adverse Opioid Effect: Emesis |
24; 15 | 0.30 |
| SECONDARY Adverse Opioid Effect: Pruritus |
81; 62 | 0.07 |
| SECONDARY Adverse Opioid Effect: Respiratory Depression |
24; 15 | 0.31 |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00880607). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.