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Efficacy Study of Ketamine for Postoperative Pain in Opioid Dependent Patients

NCT ID: NCT01591382

Last Updated: 2017-03-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2012-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Ketamine

Intervention Type DRUG

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

Hydromorphone PCA

Intervention Type DRUG

Intravenous hydromorphone PCA

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Patients who received ketamine-matching placebo were given saline infusions

Hydromorphone PCA

Intervention Type DRUG

Intravenous hydromorphone PCA

Interventions

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Ketamine

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

Intervention Type DRUG

Placebo

Patients who received ketamine-matching placebo were given saline infusions

Intervention Type DRUG

Hydromorphone PCA

Intravenous hydromorphone PCA

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Srdjan Nedeljkovic

Staff, Pain Management Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Srdjan S Nedeljkovic, M.D.

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2008P001126

Identifier Type: -

Identifier Source: org_study_id

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