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Trial record 29 of 1046 for:    scale | Norway

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00354029
Recruitment Status : Completed
First Posted : July 19, 2006
Results First Posted : July 20, 2011
Last Update Posted : July 20, 2011
Sponsor:
Information provided by:
Asker & Baerum Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Hemorrhoids
Pain
Interventions Drug: S (+) Ketamine
Drug: Placebo
Enrollment 83
Recruitment Details  
Pre-assignment Details  
Arm/Group Title S (+) Ketamine Placebo
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Overall Study
Started 43 40
Completed 39 38
Not Completed 4 2
Reason Not Completed
Protocol Violation             4             2
Arm/Group Title S (+) Ketamine Placebo Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 43 40 83
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 40 participants 83 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
43
 100.0%
40
 100.0%
83
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 43 participants 40 participants 83 participants
46.4  (11.6) 50.2  (11.4) 48  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 40 participants 83 participants
Female
26
  60.5%
22
  55.0%
48
  57.8%
Male
17
  39.5%
18
  45.0%
35
  42.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Norway Number Analyzed 43 participants 40 participants 83 participants
43 40 83
1.Primary Outcome
Title NRS Pain = Numeric Rating Scale (0-10)
Hide Description The numeric rating scale (NRS) is used to measure the intensity of pain. The value 0 means no pain and the value 10 represents maximal pain. a higher intensity of pain is associated with a worse outcome.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title S (+) Ketamine Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 43 40
Mean (Standard Deviation)
Unit of Measure: Units on a scale
1.6  (2.1) 1.5  (1.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection S (+) Ketamine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title S (+) Ketamine Placebo
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
S (+) Ketamine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
S (+) Ketamine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/43 (0.00%)   0/40 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
S (+) Ketamine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/43 (0.00%)   0/40 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ulrich J Spreng
Organization: Baerum Hospital
Phone: 004798499184
EMail: ulispreng@hotmail.com
Layout table for additonal information
Responsible Party: Ulrich Johannes Spreng, Asker and Baerum Hospital
ClinicalTrials.gov Identifier: NCT00354029     History of Changes
Other Study ID Numbers: 2006-001082-41
First Submitted: July 18, 2006
First Posted: July 19, 2006
Results First Submitted: May 24, 2011
Results First Posted: July 20, 2011
Last Update Posted: July 20, 2011