Dental Crowding
Conditions
Keywords
Third Molar, Pain
Brief summary
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.
Detailed description
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.
Interventions
DRUGNicotine
Nicotine nasal spray 3mg x 1 before surgery
OTHERPlacebo
Placebo nasal spray 0mg x 1 before surgery
Sponsors
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* over 18 * 4 molars to be removed
Exclusion criteria
* pregnant * lactating * chronic pain * narcotic use * asthma * ex-smokers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Reported by Patient | Up to 1 day | Pain were reported on the numerical rating scale for pain (NRS) with 0=no pain and 10=worst pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate | 5 days | Heart rate reported in beats per minute (BPM) |
| Systolic Blood Pressure | 5 days | Systolic blood pressure reported in Millimeters of Mercury (mmHg) |
| Diastolic Blood Pressure | 5 days | Diastolic blood pressure reported in Millimeters of Mercury (mmHg) |
| Difference in Amount of Nausea Reported | 5 days | 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. |
| Difference in Number of Hydrocodone 5 mg Acetaminophen 325 mg Tablets Taken After Surgery | 5 days | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population The baseline characteristics for the entire study population are presented here. The nicotine and placebo study populations were identical. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Age, Continuous | 23 years STANDARD_DEVIATION 5 |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Pain Reported by Patient
Pain were reported on the numerical rating scale for pain (NRS) with 0=no pain and 10=worst pain.
Time frame: Up to 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nicotine Nasal Spray | Pain Reported by Patient | 1.6 score on a scale | Standard Deviation 0.5 |
| Placebo | Pain Reported by Patient | 2.9 score on a scale | Standard Deviation 0.5 |
Secondary
Diastolic Blood Pressure
Diastolic blood pressure reported in Millimeters of Mercury (mmHg)
Time frame: 5 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nicotine Nasal Spray | Diastolic Blood Pressure | 77 Millimeters of Mercury (mmHg) | Standard Deviation 8 |
| Placebo | Diastolic Blood Pressure | 76 Millimeters of Mercury (mmHg) | Standard Deviation 10 |
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.
Time frame: 5 days
Population: 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.
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.
Time frame: 5 days
Population: 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.
Secondary
Heart Rate
Heart rate reported in beats per minute (BPM)
Time frame: 5 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nicotine Nasal Spray | Heart Rate | 81 Beats per minute (BPM) | Standard Deviation 15 |
| Placebo | Heart Rate | 76 Beats per minute (BPM) | Standard Deviation 15 |
Secondary
Systolic Blood Pressure
Systolic blood pressure reported in Millimeters of Mercury (mmHg)
Time frame: 5 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nicotine Nasal Spray | Systolic Blood Pressure | 120 Millimeters of Mercury (mmHg) | Standard Deviation 11 |
| Placebo | Systolic Blood Pressure | 121 Millimeters of Mercury (mmHg) | Standard Deviation 12 |