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Efficacy Study of Ketamine for Postoperative Pain in Opioid Dependent Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Srdjan Nedeljkovic, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01591382
First received: May 1, 2012
Last updated: February 1, 2017
Last verified: February 2017
  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
Drug: Hydromorphone PCA
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Participant, Care Provider, 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:
  • Average Postoperative Pain Score [ Time Frame: Participants were followed for the duration of hospital stay, an average of approximately 3 days. ]
    Postoperative pain scores were collected once per day during morning rounds for the preceding 24 hours. Participant were asked to provide pain scores for "worst," "average," and "least" pain using the 11-point Numerical Rating Scale (NRS), where 0 represents the absence of pain and 10 is worst possible pain. The average postoperative pain score for each treatment arm is reported.


Secondary Outcome Measures:
  • Worst Postoperative Pain Score [ Time Frame: Participants were followed for the duration of hospital stay, an average of approximately 3 days. ]
    Postoperative pain scores were collected once per day during morning rounds for the preceding 24 hours. Participant were asked to provide pain scores for "worst," "average," and "least" pain using the 11-point Numerical Rating Scale (NRS), where 0 represents the absence of pain and 10 is worst possible pain. The average worst postoperative pain score for each treatment arm is reported.

  • Least Postoperative Pain Score [ Time Frame: Participants were followed for the duration of hospital stay, an average of approximately 3 days. ]
    Postoperative pain scores were collected once per day during morning rounds for the preceding 24 hours. Participant were asked to provide pain scores for "worst," "average," and "least" pain using the 11-point Numerical Rating Scale (NRS), where 0 represents the absence of pain and 10 is worst possible pain. The average least postoperative pain score for each treatment arm is reported.

  • 24-Hour Postoperative Opioid Use [ Time Frame: For 24 hours following surgery ]
    Opioid use is defined as the total milligrams of hydromorphone plus other home or oral opioid used per 24 hours, converted to oral morphine equivalents.

  • Number of Participants With Treatment Related Adverse Events (AEs) [ Time Frame: Participants were followed for the duration of hospital stay, an average of approximately 3 days. ]
    Participants were asked to complete a "Side Effects Checklist" to assess for any unwanted side effects (AEs) of drugs that were administered. The determination of whether or not an AE was treatment related was at the discretion of the Investigator.


Enrollment: 64
Study Start Date: September 2008
Study Completion Date: June 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ketamine
Participants received postoperative hydromorphone patient-controlled analgesia (PCA) and continuous ketamine (0.2 mg/kg/hour). 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
Intravenous (IV) ketamine 0.2 mg/kg/hr for 24-48 hours postoperatively.
Drug: Hydromorphone PCA
Intravenous hydromorphone PCA
Placebo Comparator: Placebo
Participants received postoperative hydromorphone PCA and continuous ketamine-matching placebo (infusion of saline).
Drug: Placebo
Patients who received ketamine-matching placebo were given saline infusions
Drug: Hydromorphone PCA
Intravenous hydromorphone PCA

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 intravenous (IV) patient controlled analgesia (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 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

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
Results First Received: February 1, 2017
Last Updated: February 1, 2017

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

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

ClinicalTrials.gov processed this record on April 24, 2017