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Third molar surgery is complicated by pain and swelling for several days after surgery. Non-steroidal antiinflammatory drugs have been useful in combination with opioids for treatment. Nicotine has antiinflammatory and pain relieving properties. We will use nicotine or placebo as a nasal spray before surgery to determine whether nicotine affects pain or inflammation.
This is a randomized double blind cross-over study. In each of two sittings, the third molars on one side of the mouth are removed. In one sitting the subject will receive a nicotine nasal spray (3mg) and in the other placebo. VAS and narcotic utilization will be compared within patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nicotine nasal spray | Active Comparator | In one sitting the subject will receive a nicotine nasal spray, 3 mg, one application. |
|
| Placebo spray | Placebo Comparator | In one sitting the subject will receive a placebo nasal spray (0 mg), one application. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine | Drug | Nicotine nasal spray 3mg x 1 before surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Reported by Patient | Pain were reported on the numerical rating scale for pain (NRS) with 0=no pain and 10=worst pain. | Up to 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate | Heart rate reported in beats per minute (BPM) | 5 days |
| Systolic Blood Pressure | Systolic blood pressure reported in Millimeters of Mercury (mmHg) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pamela Flood, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University | New York | New York | 10032 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nicotine Nasal Spray First, Then Placebo | At the first intervention, the subject will receive a nicotine nasal spray, 3 mg, one application. At the second intervention, the subject will receive a placebo nasal spray, 0 mg, one application. |
| FG001 | Placebo Spray First, Then Nicotine | At the first intervention, the subject will receive a placebo nasal spray, 0 mg, one application. At the second intervention, the subject will receive a nicotine nasal spray, 3 mg, one application. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| |||||||||||||
| Second Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | The baseline characteristics for the entire study population are presented here. The nicotine and placebo study populations were identical. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Reported by Patient | Pain were reported on the numerical rating scale for pain (NRS) with 0=no pain and 10=worst pain. | Posted | Mean | Standard Deviation | score on a scale | Up to 1 day |
|
Up to 5 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nicotine Nasal Spray | Nicotine nasal spray (3mg) was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pamela Flood, MD | Columbia University | 212-305-2008 | pdf3@columbia.edu |
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| ID | Term |
|---|---|
| D003441 | Crowding |
| D010146 | Pain |
| ID | Term |
|---|---|
| D013037 | Spatial Behavior |
| D001519 | Behavior |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D009538 | Nicotine |
| D061485 | Tobacco Use Cessation Devices |
| D059085 | Nasal Sprays |
| ID | Term |
|---|---|
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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| Placebo | Other | Placebo nasal spray 0mg x 1 before surgery |
|
|
| 5 days |
| Diastolic Blood Pressure | Diastolic blood pressure reported in Millimeters of Mercury (mmHg) | 5 days |
| Difference in Amount of Nausea Reported | For an hour postoperatively, subjects reported information on pain and nausea, and hemodynamic variables were recorded at 15-minute intervals. Telephone follow-up was recorded for 5 days postoperatively, where patients reported information on pain, nausea, and use of hydrocodone/acetaminophen as rescue analgesia. | 5 days |
| Difference in Number of Hydrocodone 5 mg Acetaminophen 325 mg Tablets Taken After Surgery | All patients were prescribed Hydrocodone 5 mg / Acetaminophen 325 mg and were instructed to take 1 to 2 tablets for oral pain at a maximum of every 4 to 6 hours post-surgery. | 5 days |
| NOT COMPLETED |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Heart Rate | Heart rate reported in beats per minute (BPM) | Posted | Mean | Standard Deviation | Beats per minute (BPM) | 5 days |
|
|
|
| Secondary | Systolic Blood Pressure | Systolic blood pressure reported in Millimeters of Mercury (mmHg) | Posted | Mean | Standard Deviation | Millimeters of Mercury (mmHg) | 5 days |
|
|
|
| Secondary | Diastolic Blood Pressure | Diastolic blood pressure reported in Millimeters of Mercury (mmHg) | Posted | Mean | Standard Deviation | Millimeters of Mercury (mmHg) | 5 days |
|
|
|
| Secondary | Difference in Amount of Nausea Reported | For an hour postoperatively, subjects reported information on pain and nausea, and hemodynamic variables were recorded at 15-minute intervals. Telephone follow-up was recorded for 5 days postoperatively, where patients reported information on pain, nausea, and use of hydrocodone/acetaminophen as rescue analgesia. | The difference in the amount of nausea was not calculated. Raw data existed during the study period of 2004 to 2009. This record was completed and published in 2010 without results for this outcome measure. The data was subsequently destroyed because the data retention period had ended. As of the current year, 2024, all the raw data for this study no longer exists. This outcome cannot be calculated without the raw data. | Posted | 5 days |
|
|
| Secondary | Difference in Number of Hydrocodone 5 mg Acetaminophen 325 mg Tablets Taken After Surgery | All patients were prescribed Hydrocodone 5 mg / Acetaminophen 325 mg and were instructed to take 1 to 2 tablets for oral pain at a maximum of every 4 to 6 hours post-surgery. | The difference in the amount of nausea was not calculated. Raw data existed during the study period of 2004 to 2009. This record was completed and published in 2010 without results for this outcome measure. The data was subsequently destroyed because the data retention period had ended. As of the current year, 2024, all the raw data for this study no longer exists. This outcome cannot be calculated without the raw data. | Posted | 5 days |
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Placebo | Sterile saline nasal spray was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period. | 0 | 20 | 0 | 20 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D013812 | Therapeutics |
| D000336 | Aerosols |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |