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Completed

NCT Number: NCT01591382

Efficacy Study of Ketamine for Postoperative Pain in Opioid Dependent Patients

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ketamine

Drug

Intravenous (IV) ketamine 0.2 mg/kg/hr for 24-48 hours postoperatively.

Placebo

Drug

Patients who received ketamine-matching placebo were given saline infusions

Hydromorphone PCA

Drug

Intravenous hydromorphone PCA

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
May 4, 2012
Registry last updated
Mar 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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