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

Sponsor:	Asker & Baerum Hospital
Information provided by:	Asker & Baerum Hospital
ClinicalTrials.gov Identifier:	NCT00354029

Purpose

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	Intervention	Phase
Hemorrhoids Pain	Drug: S (+) Ketamine Drug: Placebo	Phase 4

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
Official Title:	Effect of Perioperative i.v. Low-dose S(+) Ketamine in Patients Undergoing Hemorrhoidectomy

Resource links provided by NLM:

MedlinePlus related topics: Hemorrhoids

Drug Information available for: Ketamine hydrochloride Ketamine

U.S. FDA Resources

Further study details as provided by Asker & Baerum Hospital:

Primary Outcome Measures:

NRS Pain = Numeric Rating Scale (0-10) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
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.

Enrollment:	83
Study Start Date:	August 2006
Study Completion Date:	May 2009
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo Saline 0,9%	Drug: Placebo isotonic saline
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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00354029

Locations

Norway
Asker and Baerum Hospital
Rud, Norway, N-1309

Sponsors and Collaborators

Asker & Baerum Hospital

Investigators

Principal Investigator:	Ulrich J Spreng, Dr. med,	Asker and Baerum Hospital, Norway
Study Director:	Vegard Dahl, Dr. med.	Asker and Baerum Hospital, Norway

More Information

Publications:

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.

Himmelseher S, Durieux ME. Ketamine for perioperative pain management. Anesthesiology. 2005 Jan;102(1):211-20. Review. No abstract available.

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. Review.

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

Keywords provided by Asker & Baerum Hospital:

hemorrhoids
hemorrhoidectomy
S (+) ketamine
pain

Additional relevant MeSH terms:

Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Ketamine
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 24, 2012