Effect of Perioperative i.v. Low-dose S(+) Ketamine
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|ClinicalTrials.gov Identifier: NCT00354029|
Recruitment Status : Completed
First Posted : July 19, 2006
Results First Posted : July 20, 2011
Last Update Posted : July 20, 2011
The purpose of this study is to determine whether the use of perioperative intravenous S (+) ketamine reduces the amount and degree of postoperative pain.
Furthermore the purpose of this study is to determine whether the use of perioperative intravenous S (+) ketamine effects cognitive function in the early postoperative period.
|Condition or disease||Intervention/treatment||Phase|
|Hemorrhoids Pain||Drug: S (+) Ketamine Drug: Placebo||Phase 4|
The mechanism of development of postoperative pain is complex. Central and peripheral sensitization are playing an important role and this can lead to postoperative hypersensitization. Several studies have shown, that S (+) ketamine can be effective to reduce sensitization and postoperative pain. Ketamine (2-O-chlorophenyl-2-methylamino cyclohexanone) is a N-Methyl-D-Aspartat (NMDA) receptor antagonist. S (+) ketamine has a four times stronger affinity to the NMDA receptor compared to R (-) ketamine. The duration of action for S (+) ketamine is shorter than R (-) ketamine and it has fewer side-effects.
The purpose of this study is to compare the analgetic effect of pregabalin and placebo used in the perioperative period.
The hypothesis is that perioperative intravenous S (+) ketamine gives significant better analgesia than placebo without effecting cognitive function.
The study is including patients undergoing hemorrhoidectomy.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||83 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Perioperative i.v. Low-dose S(+) Ketamine in Patients Undergoing Hemorrhoidectomy|
|Study Start Date :||August 2006|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||May 2009|
Placebo Comparator: Placebo
|Active Comparator: S (+) Ketamine||
Drug: S (+) Ketamine
0,35 mg/kg bolus after induction of anaesthesia; 5 ug/kg/min. continuous until the end of surgery
- NRS Pain = Numeric Rating Scale (0-10) [ Time Frame: 24 hours ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00354029
|Asker and Baerum Hospital|
|Rud, Norway, N-1309|
|Principal Investigator:||Ulrich J Spreng, Dr. med,||Asker and Baerum Hospital, Norway|
|Study Director:||Vegard Dahl, Dr. med.||Asker and Baerum Hospital, Norway|