Back to resultsEffect of Perioperative i.v. Low-dose S(+) Ketamine
Primary Purpose
Hemorrhoids, Pain
Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
S (+) Ketamine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hemorrhoids focused on measuring hemorrhoids, hemorrhoidectomy, S (+) ketamine, pain
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of disc prolapse Age 18+ ASA (American Society in Anesthesiology) I-II written consent Exclusion Criteria: Age < 18 ASA > II liver failure renal failure heart failure glaucoma pregnancy
Sites / Locations
- Asker and Baerum Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
S (+) Ketamine
Arm Description
Saline 0,9%
Outcomes
Primary Outcome Measures
NRS Pain = Numeric Rating Scale (0-10)
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00354029
Brief Title
Effect of Perioperative i.v. Low-dose S(+) Ketamine
Official Title
Effect of Perioperative i.v. Low-dose S(+) Ketamine in Patients Undergoing Hemorrhoidectomy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Asker & Baerum Hospital
4. Oversight
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhoids, Pain
Keywords
hemorrhoids, hemorrhoidectomy, S (+) ketamine, pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
83 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Saline 0,9%
Arm Title
S (+) Ketamine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
S (+) Ketamine
Intervention Description
0,35 mg/kg bolus after induction of anaesthesia; 5 ug/kg/min. continuous until the end of surgery
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
isotonic saline
Primary Outcome Measure Information:
Title
NRS Pain = Numeric Rating Scale (0-10)
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of disc prolapse
Age 18+
ASA (American Society in Anesthesiology) I-II
written consent
Exclusion Criteria:
Age < 18
ASA > II
liver failure
renal failure
heart failure
glaucoma
pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrich J Spreng, Dr. med,
Organizational Affiliation
Asker and Baerum Hospital, Norway
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vegard Dahl, Dr. med.
Organizational Affiliation
Asker and Baerum Hospital, Norway
Official's Role
Study Director
Facility Information:
Facility Name
Asker and Baerum Hospital
City
Rud
ZIP/Postal Code
N-1309
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
8957979
Citation
Arendt-Nielsen L, Nielsen J, Petersen-Felix S, Schnider TW, Zbinden AM. Effect of racemic mixture and the (S+)-isomer of ketamine on temporal and spatial summation of pain. Br J Anaesth. 1996 Nov;77(5):625-31. doi: 10.1093/bja/77.5.625.
Results Reference
background
PubMed Identifier
15618805
Citation
Himmelseher S, Durieux ME. Ketamine for perioperative pain management. Anesthesiology. 2005 Jan;102(1):211-20. doi: 10.1097/00000542-200501000-00030. No abstract available.
Results Reference
background
PubMed Identifier
16223384
Citation
Bell RF, Dahl JB, Moore RA, Kalso E. Peri-operative ketamine for acute post-operative pain: a quantitative and qualitative systematic review (Cochrane review). Acta Anaesthesiol Scand. 2005 Nov;49(10):1405-28. doi: 10.1111/j.1399-6576.2005.00814.x.
Results Reference
background
Learn more about this trial
Effect of Perioperative i.v. Low-dose S(+) Ketamine
We'll reach out to this number within 24 hrs