Escalating Ketamine Doses and Pre-emption

NCT ID: NCT01070108

Last Updated: 2010-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2009-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Pain Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Set 1

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

Group Type ACTIVE_COMPARATOR

Ketamine

Intervention Type DRUG

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

ketamine

Intervention Type DRUG

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

ketamine

Intervention Type DRUG

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

set 2

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

Group Type ACTIVE_COMPARATOR

ketamine

Intervention Type DRUG

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

ketamine

Intervention Type DRUG

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

set 3

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

Group Type ACTIVE_COMPARATOR

ketamine

Intervention Type DRUG

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

Interventions

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Ketamine

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

Intervention Type DRUG

ketamine

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

Intervention Type DRUG

ketamine

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Tel Aviv Medical Center

Locations

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Tel Aviv Medical Center

Tel Aviv, , Israel

Site Status

Countries

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Israel

References

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Rakhman E, Shmain D, White I, Ekstein MP, Kollender Y, Chazan S, Dadia S, Bickels J, Amar E, Weinbroum AA. Repeated and escalating preoperative subanesthetic doses of ketamine for postoperative pain control in patients undergoing tumor resection: a randomized, placebo-controlled, double-blind trial. Clin Ther. 2011 Jul;33(7):863-73. doi: 10.1016/j.clinthera.2011.05.094. Epub 2011 Jul 1.

Reference Type DERIVED
PMID: 21722959 (View on PubMed)

Other Identifiers

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ketamine

Identifier Type: -

Identifier Source: org_study_id

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