Efficacy Study of Ketamine for Postoperative Pain in Opioid Dependent Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Brigham and Women's Hospital.
Recruitment status was  Active, not recruiting
Information provided by (Responsible Party):
Srdjan Nedeljkovic, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
First received: May 1, 2012
Last updated: May 2, 2012
Last verified: May 2012
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.

Condition Intervention Phase
Postoperative Pain
Drug: Ketamine
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hydromorphone PCA or Hydromorphone PCA With Ketamine for Acute Postoperative Pain Relief in Opioid-Dependent Chronic Pain Patients

Resource links provided by NLM:

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Pain relief [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days ] [ Designated as safety issue: No ]
    Evaluate efficacy of ketamine for postop pain control in opioid-dependent patients who receive ketamine in addition to postop patient controlled analgesia with opioids

Enrollment: 64
Study Start Date: September 2008
Estimated Study Completion Date: June 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ketamine
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.
Drug: Ketamine
IV ketamine 0.2 mg/kg/hr for 24-48 hours postoperatively.
Placebo Comparator: Placebo
Patients who received placebo recieved an infusion of saline.
Drug: Placebo
Patients who received placebo were given saline infusions


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01591382

United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Principal Investigator: Srdjan S Nedeljkovic, M.D. Brigham and Women's Hospital
  More Information

Responsible Party: Srdjan Nedeljkovic, Staff, Pain Management Center, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01591382     History of Changes
Other Study ID Numbers: 2008P001126 
Study First Received: May 1, 2012
Last Updated: May 2, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Postoperative pain
Opioid dependent patients
Acute pain control

Additional relevant MeSH terms:
Pain, Postoperative
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Anesthetics, Dissociative
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 27, 2016