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

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.

Study Overview

• Status: Completed
• Conditions: Post-Operative Pain; Third Molar Extraction
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Actual): 225
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 4; Intravenous morphine	Drug: Intravenous morphine; Intravenous morphine 7.5 mg
Experimental: 1; Intranasal morphine 7.5 mg	Drug: Intranasal morphine 7.5 mg; Intranasal morphine 7.5 mg
Experimental: 2; Intranasal morphine 15 mg	Drug: Intranasal Morphine 15 mg; Intranasal Morphine 15 mg
Active Comparator: 3; Oral morphine 60 mg	Drug: Immediate Release Oral Morphine 60 mg; Immediate Release Oral Morphine 60 mg
Placebo Comparator: 5; Intranasal placebo	Drug: Intranasal Placebo; Intranasal placebo
Placebo Comparator: 6; Oral placebo	Drug: Oral placebo; Oral placebo
Placebo Comparator: 7; Intravenous placebo	Drug: Intravenous placebo; Intravenous placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Other measures of pain relief	Several time points

Collaborators and Investigators

• Sponsor: Javelin Pharmaceuticals
• Investigators: Principal Investigator: Kyle Christensen, DDS, Jean Brown Associates, Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2001
• Primary Completion (Actual): November 1, 2001
• Study Completion (Actual): November 1, 2001

Study Registration Dates

• First Submitted: October 17, 2006
• First Submitted That Met QC Criteria: October 17, 2006
• First Posted (Estimate): October 19, 2006

Study Record Updates

• Last Update Posted (Estimate): January 4, 2008
• Last Update Submitted That Met QC Criteria: December 28, 2007
• Last Verified: December 1, 2007

More Information

Terms related to this study

• Keywords: Morphine; Dental surgery; Post operative pain; Third molar extraction
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: MOR-001