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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4 | Active Comparator | Intravenous morphine |
|
| 1 | Experimental | Intranasal morphine 7.5 mg |
|
| 2 | Experimental | Intranasal morphine 15 mg |
|
| 3 | Active Comparator | Oral morphine 60 mg |
|
| 5 | Placebo Comparator | Intranasal placebo |
|
| 6 | Placebo Comparator | Oral placebo |
|
| 7 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intranasal Placebo | Drug | Intranasal placebo |
| |
| Intranasal Morphine 15 mg |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Other measures of pain relief | Several time points |
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Inclusion Criteria:
Exclusion Criteria:
Additional Inclusion/Exclusion Criteria May Apply
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| Name | Affiliation | Role |
|---|---|---|
| Kyle Christensen, DDS | Jean Brown Associates, Inc. | Principal Investigator |
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| Placebo Comparator |
Intravenous placebo |
|
| Drug |
Intranasal Morphine 15 mg |
|
| Immediate Release Oral Morphine 60 mg | Drug | Immediate Release Oral Morphine 60 mg |
|
| Intravenous morphine | Drug | Intravenous morphine 7.5 mg |
|
| Intranasal morphine 7.5 mg | Drug | Intranasal morphine 7.5 mg |
|
| Oral placebo | Drug | Oral placebo |
|
| Intravenous placebo | Drug | Intravenous placebo |
|
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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