Escalating Ketamine Doses and Pre-emption

• Sponsor: Tel-Aviv Sourasky Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01070108
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 3
• Duration (Months): 24
• Patients Per Site Per Month: 5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain Management	Drug: Ketamine; Drug: ketamine; Drug: ketamine	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: EARLY PREOPERATIVE ESCALATING DOSES OF KETAMINE ATTENUATE POSTOPERATIVE PAIN AND REDUCE MORPHINE CONSUMPTION IN HUMANS
• Study Start Date: Jan 1, 2007
• Actual Primary Completion Date: Jan 1, 2009
• Actual Study Completion Date: Jan 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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)	Drug: Ketamine; 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; ketamine at 11-12 hours (10 mg) and 3-4 hours (25 mg) before surgery (K2), with a corresponding NS group; 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
Active Comparator: 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	Drug: ketamine; ketamine at 11-12 hours (10 mg) and 3-4 hours (25 mg) before surgery (K2), with a corresponding NS group; 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
Active Comparator: 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	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

Outcome Measures

Primary Outcome Measures

1. postoperative pain [48 hours]

Secondary Outcome Measures

1. opioid drug consumption [48 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tel Aviv Medical Center	Tel Aviv		Israel

Sponsors and Collaborators

• Tel-Aviv Sourasky Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01070108
• Other Study ID Numbers: ketamine
• First Posted: Feb 17, 2010
• Last Update Posted: Feb 17, 2010
• Last Verified: Feb 1, 2010

• Keywords provided by , ,: Preemption, ketamine, escalating, dose, pain, analgesia
• Additional relevant MeSH terms: Pain, Postoperative; Ketamine

Study Results

No Results Posted as of Feb 17, 2010