Escalating Ketamine Doses and Pre-emption

Study Overview
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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.

Official Title
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EARLY PREOPERATIVE ESCALATING DOSES OF KETAMINE ATTENUATE POSTOPERATIVE PAIN AND REDUCE MORPHINE CONSUMPTION IN HUMANS

Conditions
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Postoperative Pain Management

Intervention / Treatment
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* Drug: Ketamine
* Drug: ketamine
* Drug: ketamine


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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Set 1<br>group receiving one injection (25 mg) of ketamine (K1) intramuscularly (IM) at 3-4 hours before surgery or placebo (saline 0.9%, NS) | Drug: Ketamine<br>* group receiving one injection (25 mg) of ketamine (K1) intramuscularly (IM) at 3-4 hours before surgery or placebo (saline 0.9%, NS)<br>Drug: ketamine<br>* ketamine at 11-12 hours (10 mg) and 3-4 hours (25 mg) before surgery (K2), with a corresponding NS group<br>Drug: ketamine<br>* 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<br>|
| Active Comparator: set 2<br>2nd set received ketamine at 11-12 hours (10 mg) and 3-4 hours (25 mg) before surgery (K2), with a corresponding NS group | Drug: ketamine<br>* ketamine at 11-12 hours (10 mg) and 3-4 hours (25 mg) before surgery (K2), with a corresponding NS group<br>Drug: ketamine<br>* 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<br>|
| Active Comparator: set 3<br>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 | Drug: ketamine<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| opioid drug consumption |  | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preemption, ketamine, escalating, dose, pain, analgesia