Efficacy Study of Ketamine for Postoperative Pain in Opioid Dependent Patients

Overview

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.

Full Title of Study: “Hydromorphone PCA or Hydromorphone PCA With Ketamine for Acute Postoperative Pain Relief in Opioid-Dependent Chronic Pain Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 2011

Interventions

  • Drug: Ketamine
    • Intravenous (IV) ketamine 0.2 mg/kg/hr for 24-48 hours postoperatively.
  • Drug: Placebo
    • Patients who received ketamine-matching placebo were given saline infusions
  • Drug: Hydromorphone PCA
    • Intravenous hydromorphone PCA

Arms, Groups and Cohorts

  • 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.
  • Placebo Comparator: Placebo
    • Participants received postoperative hydromorphone PCA and continuous ketamine-matching placebo (infusion of saline).

Clinical Trial Outcome Measures

Primary 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 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Brigham and Women’s Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Srdjan Nedeljkovic, Staff, Pain Management Center – Brigham and Women’s Hospital
  • Overall Official(s)
    • Srdjan S Nedeljkovic, M.D., Principal Investigator, Brigham and Women’s Hospital

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