Phase 2
Completed N=129
A Comparison of Ketamine Infusion Versus Placebo in Opioid Tolerant and Opioid Naive Patients After Spinal Fusion
Spinal Fusion
Source: ClinicalTrials.gov NCT03274453 ↗
Enrolled (actual)
129
Serious AEs
0.0%
Results posted
Jun 2018
Primary outcomePrimary: Hydromorphone Use/24 Hours postOP in mg/kg — .13; .09; .27; .19 mg/kg
Summary
The aim of the proposed study is to examine the effectiveness of low dose postoperative ketamine infusion as an analgesic adjuvant to morphine pca in opioid tolerant and opioid naïve patients after major spine surgery. Primary endpoints of the study are to determine the effectiveness of postoperative ketamine infusion in for the reduction of postoperative pain and opioid requirements.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hydromorphone Use/24 Hours postOP in mg/kg |
.13; .09; .27; .19 | — |
Eligibility Criteria
Inclusion Criteria
- Adult and teenage (>/=16) male or female who will undergo surgery for multilevel (>4 level) spinal fusion from a posterior approach with general anesthesia, and who are fluent English speakers such that they can complete the pain score and satisfaction questionnaires whose scores are a critical outcome variable.
- If female, subject is non-lactating and is either:
- Not of childbearing potential
- Of childbearing potential but is not pregnant at time of baseline as determined by pre-surgical pregnancy testing.
- Subject is ASA physical status 1, 2, or 3.
Exclusion Criteria
- anxiety
- psychiatric disorder
- Allergy or sensitivity to ketamine or dilaudid
- Deemed un-acceptable by study team
- Cognitively impaired (by history)
- Subject requires chronic antipsychotic medication
- Subject known to be in liver failure
- Subject for whom opioids or ketamine are contraindicated
- Patients with narrow angle glaucoma
- Patients with a history of psychosis
Data sourced from ClinicalTrials.gov (NCT03274453). 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.