Phase 4
N=64
Efficacy Study of Ketamine for Postoperative Pain in Opioid Dependent Patients
Postoperative Pain
Bottom Line
View on ClinicalTrials.gov: NCT01591382 ↗Enrolled (actual)
64
Serious AEs
3.6%
Results posted
Mar 2017
Primary outcome: Primary: Average Postoperative Pain Score — 6.0; 7.3 units on a scale — p=0.0241
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ketamine (Drug); Placebo (Drug); Hydromorphone PCA (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Postoperative Pain Score |
6.0; 7.3 | 0.0241 sig |
| SECONDARY Worst Postoperative Pain Score |
8.7; 9.0 | 0.4102 |
| SECONDARY Least Postoperative Pain Score |
4.4; 5.6 | 0.1085 |
| SECONDARY 24-Hour Postoperative Opioid Use |
726; 770 | 0.7480 |
| SECONDARY Number of Participants With Treatment Related Adverse Events (AEs) |
0; 0; 1; 0; 5; 2 | — |
Summary
Patients who are dependent on opioids often have poor pain relief after major surgery. This study tests the hypothesis that adding intravenous ketamine to a postoperative regimen of intravenous opioids for postoperative pain will improve pain relief in this subset of patients.
Eligibility Criteria
Inclusion Criteria
- Chronic pain > 6 months
- Long term use of opioids
- Major surgery
Exclusion Criteria
- Use of regional anesthetic techniques
- No need for intravenous (IV) patient controlled analgesia (PCA) after surgery
Data sourced from ClinicalTrials.gov (NCT01591382). 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.