Ketamine on Acute Pain in Females and Males
Information source: Oslo University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Mouth and Tooth Diseases; Tooth, Impacted
Intervention: Placebo males (Drug); Ketamine 0,1 mg/kg males (Drug); Ketamine 0,3 mg/kg males (Drug); Ketamine 0,5 mg/kg males (Drug); Placebo females (Drug); Ketamine 0,1 mg/kg females (Drug); Ketamine 0,3 mg/kg females (Drug); Ketamine 0,5 mg/kg females (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Ullevaal University Hospital Official(s) and/or principal investigator(s):
Lasse A Skoglund, DDS, PhD, Study Chair, Affiliation: Section of Dental Pharmacology and Pharmacotherapy, Faculty of Dentistry, POB 1119 Blindern, University of Oslo, N-0317 Oslo, Norway
Olav Hustveit, MD, Principal Investigator, Affiliation: Section of Dental Pharmacology and Pharmacotherapy, Faculty of Dentistry, POB 1119 Blindern, University of Oslo, N-0317 Oslo, Norway
Summary
The purpose of the study is to determine whether equal subanesthetic doses of racemic
ketamine is equally effective on females and males after surgical removal of third molars
Clinical Details
Official title: Effect of Racemic Ketamine on Pain in Females and Males After Surgical Removal of Third Molars
Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Sum pain NRS
Secondary outcome: Several subjective variables assessing psychotomimetic effects
Detailed description:
Ketamine is assumed to be a NMDA receptor antagonist which provides analgesia from acute
postoperative pain(and other types of pain) subanesthetic doses. Gender differences in
ketamine analgesia are not known. This placebo-controlled,randomised, parallel group study
investigates the analgesic dose-response effect of ketamine in subanesthetic doses in female
and male patients following surgical removal of third molars.
Comparisons: Placebo and ketamine in females and males.
Eligibility
Minimum age: 20 Years.
Maximum age: 30 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Indication for removal of third molar
- Between 20 and 30 years of age
- ASA Class 1
Exclusion Criteria:
- Psychiatric family (father/mother) or own anamnestic history
- Hypersensitivity towards NSAIDS or other rescue analgesics
- Verified or suspected pregnancy
- Lactating females
- Surgery lasting over 60 min
Locations and Contacts
Department of Oral and Maxillofacial Surgery, Ullevaal University Hospital, Oslo NO-0407, Norway
Additional Information
Related publications: Oye I, Mathisen LC. The effect of CPP in neurogenic pain: inhibition of spinal or cortical NMDA receptors? Pain. 1993 Jun;53(3):358-60. Øye I, Hustveit O, Maurset A, Ratti Moberg E, Paulsen O, Skoglund LA. The chiral forms of ketamine as probes for NMDA receptor functions in humans. In: NMDA receptor related agents: Biochemistry, pharmacology and behaviour. Kameyama T, Domino E (eds). NPP Books, Ann Arbor, 1991.
Starting date: January 2005
Last updated: July 3, 2011
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