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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Post-Operative Pain, Third Molar Extraction

Intervention / Treatment
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* Drug: Intranasal Placebo
* Drug: Intranasal Morphine 15 mg
* Drug: Immediate Release Oral Morphine 60 mg
* Drug: Intravenous morphine
* Drug: Intranasal morphine 7.5 mg
* Drug: Oral placebo
* Drug: Intravenous placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post operative pain, Third molar extraction, Dental surgery, Morphine