Phase 4 Completed N=64 Randomized Quadruple-blind Treatment

Efficacy Study of Ketamine for Postoperative Pain in Opioid Dependent Patients

Postoperative Pain

Source: ClinicalTrials.gov NCT01591382 ↗

Enrolled (actual)

Serious AEs

3.6%

Results posted

Mar 2017

Primary outcomePrimary: Average Postoperative Pain Score — 6.0; 7.3 units on a scale — p=0.0241

◆ 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 This can indicate results are unpublished — a known publication-bias signal.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

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.

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	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.