Efficacy Study of Ketamine for Postoperative Pain in Opioid Dependent Patients

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01591382
• Other study ID #: 2008P001126
• Status: Active, not recruiting
• Phase: Phase 4
• First received: May 1, 2012
• Last updated: May 2, 2012
• Start date: September 2008
• Est. completion date: June 2012

Study information

• Verified date: May 2012
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 64
• Est. completion date: June 2012
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Chronic pain > 6 months

• Long term use of opioids

• Major surgery

Exclusion Criteria:

• Use of regional anesthetic techniques

• No need for IV PCA after surgery

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Ketamine
IV ketamine 0.2 mg/kg/hr for 24-48 hours postoperatively.
• Placebo
Patients who received placebo were given saline infusions

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain relief	Evaluate efficacy of ketamine for postop pain control in opioid-dependent patients who receive ketamine in addition to postop patient controlled analgesia with opioids	Participants will be followed for the duration of hospital stay, an expected average of 3 days	No