Overview

This trial is active, not recruiting.

Condition postoperative pain
Treatments ketamine, placebo
Phase phase 4
Sponsor Brigham and Women's Hospital
Start date September 2008
End date June 2011
Trial size 64 participants
Trial identifier NCT01591382, 2008P001126

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Ketamine is being compared to the use of placebo, in addition to intravenous opioids, for postop pain control in opioid dependent patients who undergo major surgery.
ketamine
IV ketamine 0.2 mg/kg/hr for 24-48 hours postoperatively.
(Placebo Comparator)
Patients who received placebo recieved an infusion of saline.
placebo
Patients who received placebo were given saline infusions

Primary Outcomes

Measure
Pain relief
time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Chronic pain > 6 months - Long term use of opioids - Major surgery Exclusion Criteria: - Use of regional anesthetic techniques - No need for IV PCA after surgery

Additional Information

Official title Hydromorphone PCA or Hydromorphone PCA With Ketamine for Acute Postoperative Pain Relief in Opioid-Dependent Chronic Pain Patients
Principal investigator Srdjan S Nedeljkovic, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in May 2012.
Information provided to ClinicalTrials.gov by Brigham and Women's Hospital.