NCT00390312

Efficacy and Safety of Intranasal Morphine for Pain After Third Molar Extraction

Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Single Dose Comparison of Analgesic Efficacy and Safety of Intranasal Morphine, Immediate Release Oral Morphine, Intravenous Morphine and Placebo in Postsurgical Dental Pain

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 225 (actual)
• Sponsor: Javelin Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

This study involves approximately 200 patients designed to evaluate the efficacy and safety of intranasal (IN) morphine 7.5 mg and 15 mg, intravenous morphine (IV) 7.5 mg, immediate release oral (PO) morphine 60 mg or placebo in patients with acute postsurgical pain following third molar extraction.

Detailed description

Diagnosis and Main Criteria for Inclusion: Dental outpatients undergoing the removal of 3 or more third molars (2 of which were required to be mandibular and both must be bony impacted third molars).

Conditions

• Post-Operative Pain
• Third Molar Extraction

Interventions

Type	Name	Description
DRUG	Intranasal Placebo	Intranasal placebo
DRUG	Intranasal Morphine 15 mg	Intranasal Morphine 15 mg
DRUG	Immediate Release Oral Morphine 60 mg	Immediate Release Oral Morphine 60 mg
DRUG	Intravenous morphine	Intravenous morphine 7.5 mg
DRUG	Intranasal morphine 7.5 mg	Intranasal morphine 7.5 mg
DRUG	Oral placebo	Oral placebo
DRUG	Intravenous placebo	Intravenous placebo

Timeline

• Start date: 2001-09-01
• Primary completion: 2001-11-01
• Completion: 2001-11-01
• First posted: 2006-10-19
• Last updated: 2008-01-04