Escalating Ketamine Doses and Pre-emption

• ClinicalTrials.gov Identifier: NCT01070108
• Recruitment Status: Completed
• First Posted: February 17, 2010
• Last Update Posted: February 17, 2010
• Sponsor: Tel-Aviv Sourasky Medical Center
• Information provided by: Tel-Aviv Sourasky Medical Center

Tracking Information

• First Submitted Date: February 16, 2010
• First Posted Date: February 17, 2010
• Last Update Posted Date: February 17, 2010
• Study Start Date: January 2007
• Actual Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 16, 2010): postoperative pain [ Time Frame: 48 hours ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures (submitted: February 16, 2010): opioid drug consumption [ Time Frame: 48 hours ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Postoperative Pain Management

Intervention

• 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

Study Arms

• 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)
  Interventions:

  • Drug: Ketamine
  • Drug: ketamine
  • Drug: ketamine
• 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
  Interventions:

  • Drug: ketamine
  • Drug: ketamine
• 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
  Intervention: Drug: ketamine

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 16, 2010): 120
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: January 2009
• Actual Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 15 Years to 75 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Israel

Administrative Information

• NCT Number: NCT01070108
• Other Study ID Numbers: ketamine
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Weinbroum Avraham, Tel Aviv Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Tel-Aviv Sourasky Medical Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Tel-Aviv Sourasky Medical Center
• Verification Date: February 2010