Safety and Efficacy of Intranasal Ketamine for the Treatment of Postoperative Dental Pain

Phase 2

Completed

• Conditions: Pain, Postoperative
• Interventions: Drug: intranasal ketamine; Drug: placebo

• Registration Number: NCT00488787
• Lead Sponsor: Javelin Pharmaceuticals

Brief Summary

Once patients' postoperative pain intensity reaches a moderate-to-severe level, they are randomized to receive intranasal ketamine or placebo. Patients remain in the study unit for 3 hours post administration and assess pain intensity and pain relief throughout the 3 hour postoperative period.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-03
• Primary Completion: 2001-04
• Study Completion: 2001-04
• Study First Submitted: 2007-06-19
• Study First Submitted QC: 2007-06-19
• Study First Posted: 2007-06-20
• Status Verified: 2008-02
• Last Update Submitted: 2008-02-05
• Last Update Posted: 2008-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Healthy patients at least 16 years of age requiring two or more third molar extractions

Exclusion Criteria

• Less than 16 years old
• Other exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C	intranasal ketamine	intranasal ketamine high dose
D	placebo	placebo
B	intranasal ketamine	intranasal ketamine medium dose
A	intranasal ketamine	Intranasal ketamine low dose

Primary Outcome Measures

Name	Time	Method
total pain relief over 0-3 hours following dosing	3 hours

Secondary Outcome Measures

Name	Time	Method
other pain assessments	3 hours