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Efficacy Study of Ketamine for Postoperative Pain in Opioid Dependent Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Srdjan Nedeljkovic, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01591382
First received: May 1, 2012
Last updated: May 2, 2012
Last verified: May 2012
History of Changes
  Purpose

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:

U.S. FDA Resources

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

  Eligibility

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

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

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

No publications provided

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:
Ketamine
Postoperative pain
Opioid dependent patients
Acute pain control

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

ClinicalTrials.gov processed this record on May 23, 2013