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

Phase 2

Completed

• Conditions: Post-Operative Pain; Third Molar Extraction
• Interventions: Drug: Intravenous morphine; Drug: Intranasal morphine 7.5 mg; Drug: Intranasal Morphine 15 mg; Drug: Immediate Release Oral Morphine 60 mg; Drug: Intranasal Placebo; Drug: Oral placebo; Drug: Intravenous placebo

• Registration Number: NCT00390312
• Lead Sponsor: Javelin Pharmaceuticals

Brief 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).

Study Timeline

• Study Start: 2001-09
• Primary Completion: 2001-11
• Study Completion: 2001-11
• Study First Submitted: 2006-10-17
• Study First Submitted QC: 2006-10-17
• Study First Posted: 2006-10-19
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-28
• Last Update Posted: 2008-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 225

Inclusion Criteria

• Male or female 18-40 years of age
• Surgical extraction of at least three or more third molars (two must be mandibular and both must be bony impacted third molars)
• Moderate or severe pain within 6 hours of completion of surgery

Exclusion Criteria

• Other oral surgical procedures during the same session except the removal of supernumerary third molars
• Evidence of nasal congestion, nasal polyps, mucosal lesions of the nostrils, postnasal drip of any etiology or any clinically significant nasal pathology that may affect the absorption of study medication or the assessment of safety
• Chronic respiratory insufficiency such that treatment with an opioid analgesic is contraindicated
• Allergy to shellfish

Additional Inclusion/Exclusion Criteria May Apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4	Intravenous morphine	Intravenous morphine
1	Intranasal morphine 7.5 mg	Intranasal morphine 7.5 mg
2	Intranasal Morphine 15 mg	Intranasal morphine 15 mg
3	Immediate Release Oral Morphine 60 mg	Oral morphine 60 mg
5	Intranasal Placebo	Intranasal placebo
6	Oral placebo	Oral placebo
7	Intravenous placebo	Intravenous placebo

Primary Outcome Measures

Name	Time	Method
Total pain relief (TOTPAR) at the 0-2 hour time interval calculated as the time-weighted sum of the Pain Relief (PR) scores for the time interval 0-2 hours	2 hours

Secondary Outcome Measures

Name	Time	Method
Other measures of pain relief	Several time points