Escalating Ketamine Doses and Pre-emption

Tel Aviv Sourasky Medical Center

Status: Completed

Conditions: Postoperative Pain Management

Treatments: Drug: ketamine; Drug: Ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT01070108

ketamine

Details and patient eligibility

About

Ketamine affects postoperative pain when administered intravenously immediately before, during or at the end of surgical procedures. We assessed the effects of multiple and escalating doses of ketamine administered many hours before surgery on postoperative pain and analgesia consumption.

Enrollment: 120 patients

Sex: All

Ages: 15 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Consecutive patients, who were scheduled to undergo general or orthopedic oncologic surgery under general anesthesia

Exclusion criteria

1. allergy to opioids, ketamine or non-steroidal anti-inflammatory drugs (NSAIDs)
2. history of lasting chronic pain or psychiatric disorders or had used opioids or psychotropic drugs of any sort during the past two weeks
3. soldiers and pregnant women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups

Set 1

Active Comparator group

Description:

group receiving one injection (25 mg) of ketamine (K1) intramuscularly (IM) at 3-4 hours before surgery or placebo (saline 0.9%, NS)

Treatment:

Drug: Ketamine

set 2

Active Comparator group

Description:

2nd set received ketamine at 11-12 hours (10 mg) and 3-4 hours (25 mg) before surgery (K2), with a corresponding NS group

Treatment:

Drug: ketamine

Drug: ketamine

set 3

Active Comparator group

Description:

3rd set one group had ketamine injected IM 17-18, 11-12, and 3-4 hours before surgery (5, 10 and 25 mg, respectively) (K3), and the second group received NS

Treatment:

Drug: ketamine

Drug: ketamine