N/A
Completed N=84
Comparison of Two Naloxone Infusion Rates on the Postoperative Recovery of Patients Undergoing Spine Fusion Surgery
Pain, Postoperative · Postoperative Nausea and Vomiting · scoliosis
Source: ClinicalTrials.gov NCT01531439 ↗
Enrolled (actual)
84
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcomePrimary: Number of Hours Until Tolerating Oral Intake — 25.9; 25.0 hours
Summary
There will be two groups in this study: one group will be given the standard infusion of naloxone, a drug which helps reduce side effects from opioids needed after surgery, and the other group will receive a higher dose. The trial is designed to determine if a higher dose of naloxone infusion will reduce side effects from opioid therapy in patients who have undergone spine fusion for scoliosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Hours Until Tolerating Oral Intake |
25.9; 25.0 | — |
| SECONDARY Severity of Itching |
2.1; 1.9 | — |
| SECONDARY Severity of Nausea |
2.0; 1.2 | — |
| SECONDARY Severity of Pain |
3.7; 4.1 | — |
Eligibility Criteria
Inclusion Criteria
- Idiopathic scoliosis requiring spine fusion surgery
- Age 10-21 years
Exclusion Criteria
- Inability to understand PCA instructions
- Allergy to: morphine, hydromorphone, fentanyl, naloxone, or diphenhydramine
- Chronic opioid therapy > 2 months
- Non-English speaking
Data sourced from ClinicalTrials.gov (NCT01531439). 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.