Efficacy Study of Ketamine for Postoperative Pain in Opioid Dependent Patients

Mass General Brigham

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain

Treatments: Drug: Ketamine; Drug: Hydromorphone PCA; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01591382

2008P001126

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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64 participants in 2 patient groups, including a placebo group

Ketamine

Active Comparator group

Description:

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.

Treatment:

Drug: Hydromorphone PCA

Drug: Ketamine

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Hydromorphone PCA

Drug: Placebo