Efficacy Study of Ketamine for Postoperative Pain in Opioid Dependent Patients

Phase 4

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Placebo; Drug: Ketamine; Drug: Hydromorphone PCA

• Registration Number: NCT01591382
• Lead Sponsor: Brigham and Women's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Primary Completion: 2011-06
• Study First Submitted: 2012-05-01
• Study First Submitted QC: 2012-05-02
• Study First Posted: 2012-05-04
• Study Completion: 2012-06
• Status Verified: 2017-02
• Results First Submitted: 2017-02-01
• Results First Submitted QC: 2017-02-01
• Last Update Submitted: 2017-02-01
• Results First Posted: 2017-03-22
• Last Update Posted: 2017-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ketamine	Hydromorphone PCA	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.
Placebo	Placebo	Participants received postoperative hydromorphone PCA and continuous ketamine-matching placebo (infusion of saline).
Placebo	Hydromorphone PCA	Participants received postoperative hydromorphone PCA and continuous ketamine-matching placebo (infusion of saline).
Ketamine	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.

Primary Outcome Measures

Name	Time	Method
Average Postoperative Pain Score	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

Name	Time	Method
24-Hour Postoperative Opioid Use	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.
Worst Postoperative Pain Score	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	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.
Number of Participants With Treatment Related Adverse Events (AEs)	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.

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States