Efficacy Study of Ketamine for Postoperative Pain in Opioid Dependent Patients

• ClinicalTrials.gov Identifier: NCT01591382
• Recruitment Status: Completed
• First Posted: May 4, 2012
• Results First Posted: March 22, 2017
• Last Update Posted: March 22, 2017
• Sponsor: Brigham and Women's Hospital
• Information provided by (Responsible Party): Srdjan Nedeljkovic, Brigham and Women's Hospital

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Postoperative Pain	Drug: Ketamine; Drug: Placebo; Drug: Hydromorphone PCA	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 64 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Quadruple (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
• Study Start Date: September 2008
• Actual Primary Completion Date: June 2011
• Actual Study Completion Date: June 2012

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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 :

1. 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.
2. 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.
3. 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.
4. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

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
• Other Study ID Numbers: 2008P001126
• First Posted: May 4, 2012
• Results First Posted: March 22, 2017
• Last Update Posted: March 22, 2017
• Last Verified: February 2017

Keywords provided by Srdjan Nedeljkovic, 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; Neurologic Manifestations; Ketamine; Hydromorphone; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Central Nervous System Depressants; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Analgesics, Opioid; Narcotics