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Clinical Trials/NCT01591382
NCT01591382CompletedPhase 4

Hydromorphone PCA or Hydromorphone PCA With Ketamine for Acute Postoperative Pain Relief in Opioid-Dependent Chronic Pain Patients

Brigham and Women's Hospital1 site in 1 country64 target enrollmentStarted: September 2008Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
64
Locations
1
Primary Endpoint
Average Postoperative Pain Score

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Ketamine

Active Comparator

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.

Intervention: Ketamine (Drug)

Ketamine

Active Comparator

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.

Intervention: Hydromorphone PCA (Drug)

Placebo

Placebo Comparator

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

Intervention: Placebo (Drug)

Placebo

Placebo Comparator

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

Intervention: Hydromorphone PCA (Drug)

Outcomes

Primary Outcomes

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 Outcomes

  • 24-Hour Postoperative Opioid Use(For 24 hours following surgery)
  • Worst Postoperative Pain Score(Participants were followed for the duration of hospital stay, an average of approximately 3 days.)
  • Least Postoperative Pain Score(Participants were followed for the duration of hospital stay, an average of approximately 3 days.)
  • Number of Participants With Treatment Related Adverse Events (AEs)(Participants were followed for the duration of hospital stay, an average of approximately 3 days.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Srdjan Nedeljkovic

Staff, Pain Management Center

Brigham and Women's Hospital

Study Sites (1)

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