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Efficacy Study of Ketamine for Postoperative Pain in Opioid Dependent Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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 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
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 ]
    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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its 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 Identifier: NCT01591382     History of Changes
Other Study ID Numbers: 2008P001126 
Study First Received: May 1, 2012
Last Updated: May 2, 2012

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

Additional relevant MeSH terms:
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on February 24, 2017