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History of Changes for Study: NCT01070108
Escalating Ketamine Doses and Pre-emption
Latest version (submitted February 16, 2010) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 16, 2010 None (earliest Version on record)
Comparison Format:

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Study NCT01070108
Submitted Date:  February 16, 2010 (v1)

Open or close this module Study Identification
Unique Protocol ID: ketamine
Brief Title: Escalating Ketamine Doses and Pre-emption
Official Title: EARLY PREOPERATIVE ESCALATING DOSES OF KETAMINE ATTENUATE POSTOPERATIVE PAIN AND REDUCE MORPHINE CONSUMPTION IN HUMANS
Secondary IDs:
Open or close this module Study Status
Record Verification: February 2010
Overall Status: Completed
Study Start: January 2007
Primary Completion: January 2009 [Actual]
Study Completion: January 2009 [Actual]
First Submitted: February 16, 2010
First Submitted that
Met QC Criteria:
February 16, 2010
First Posted: February 17, 2010 [Estimate]
Last Update Submitted that
Met QC Criteria:
February 16, 2010
Last Update Posted: February 17, 2010 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Tel-Aviv Sourasky Medical Center
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module 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.
Detailed Description:
Open or close this module Conditions
Conditions: Postoperative Pain Management
Keywords: Preemption, ketamine, escalating, dose, pain, analgesia
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 120 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. postoperative pain
[ Time Frame: 48 hours ]

Secondary Outcome Measures:
1. opioid drug consumption
[ Time Frame: 48 hours ]

Open or close this module Eligibility
Minimum Age: 15 Years
Maximum Age: 75 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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
Open or close this module Contacts/Locations
Locations: Israel
Tel Aviv Medical Center
Tel Aviv, Israel
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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