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Effect of Perioperative i.v. Low-dose S(+) Ketamine

This study has been completed.
Sponsor:
Information provided by:
Asker & Baerum Hospital
ClinicalTrials.gov Identifier:
NCT00354029
First received: July 18, 2006
Last updated: July 19, 2011
Last verified: July 2011
History of Changes
Results First Received: May 24, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Hemorrhoids
Pain
Interventions: Drug: S (+) Ketamine
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
S (+) Ketamine No text entered.
Placebo No text entered.

Participant Flow:   Overall Study
    S (+) Ketamine     Placebo  
STARTED     43     40  
COMPLETED     39     38  
NOT COMPLETED     4     2  
Protocol Violation                 4                 2  



  Baseline Characteristics
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Reporting Groups
  Description
S (+) Ketamine No text entered.
Placebo No text entered.
Total Total of all reporting groups

Baseline Measures
    S (+) Ketamine     Placebo     Total  
Number of Participants  
[units: participants]
 		  43     40     83  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     43     40     83  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  46.4  ± 11.6     50.2  ± 11.4     48  ± 11.5  
Gender  
[units: participants]
 		     
Female     26     22     48  
Male     17     18     35  
Region of Enrollment  
[units: participants]
 		     
Norway     43     40     83  



  Outcome Measures

1.  Primary:   NRS Pain = Numeric Rating Scale (0-10)   [ Time Frame: 24 hours ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Ulrich J Spreng
Organization: Baerum Hospital
phone: 004798499184
e-mail: ulispreng@hotmail.com


Publications:


Responsible Party: Ulrich Johannes Spreng, Asker and Baerum Hospital
ClinicalTrials.gov Identifier: NCT00354029     History of Changes
Other Study ID Numbers: 2006-001082-41
Study First Received: July 18, 2006
Results First Received: May 24, 2011
Last Updated: July 19, 2011
Health Authority: Norway: Norwegian Medicines Agency