Trial Outcomes & Findings for Nicotine as an Adjuvant Analgesic for Third Molar Surgery (NCT NCT00385216)
NCT ID: NCT00385216
Last Updated: 2024-09-19
Results Overview
Pain were reported on the numerical rating scale for pain (NRS) with 0=no pain and 10=worst pain.
COMPLETED
PHASE4
20 participants
Up to 1 day
2024-09-19
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
First Intervention
STARTED
|
11
|
9
|
|
First Intervention
COMPLETED
|
11
|
9
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
11
|
9
|
|
Second Intervention
COMPLETED
|
11
|
9
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nicotine as an Adjuvant Analgesic for Third Molar Surgery
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=20 Participants
The baseline characteristics for the entire study population are presented here. The nicotine and placebo study populations were identical.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
23 years
STANDARD_DEVIATION 5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 1 dayPain were reported on the numerical rating scale for pain (NRS) with 0=no pain and 10=worst pain.
Outcome measures
| Measure |
Nicotine Nasal Spray
n=20 Participants
Nicotine nasal spray (3mg) was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
|
Placebo
n=20 Participants
Sterile saline placebo was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
|
|---|---|---|
|
Pain Reported by Patient
|
1.6 score on a scale
Standard Deviation 0.5
|
2.9 score on a scale
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: 5 daysHeart rate reported in beats per minute (BPM)
Outcome measures
| Measure |
Nicotine Nasal Spray
n=20 Participants
Nicotine nasal spray (3mg) was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
|
Placebo
n=20 Participants
Sterile saline placebo was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
|
|---|---|---|
|
Heart Rate
|
81 Beats per minute (BPM)
Standard Deviation 15
|
76 Beats per minute (BPM)
Standard Deviation 15
|
SECONDARY outcome
Timeframe: 5 daysSystolic blood pressure reported in Millimeters of Mercury (mmHg)
Outcome measures
| Measure |
Nicotine Nasal Spray
n=20 Participants
Nicotine nasal spray (3mg) was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
|
Placebo
n=20 Participants
Sterile saline placebo was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
|
|---|---|---|
|
Systolic Blood Pressure
|
120 Millimeters of Mercury (mmHg)
Standard Deviation 11
|
121 Millimeters of Mercury (mmHg)
Standard Deviation 12
|
SECONDARY outcome
Timeframe: 5 daysDiastolic blood pressure reported in Millimeters of Mercury (mmHg)
Outcome measures
| Measure |
Nicotine Nasal Spray
n=20 Participants
Nicotine nasal spray (3mg) was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
|
Placebo
n=20 Participants
Sterile saline placebo was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
|
|---|---|---|
|
Diastolic Blood Pressure
|
77 Millimeters of Mercury (mmHg)
Standard Deviation 8
|
76 Millimeters of Mercury (mmHg)
Standard Deviation 10
|
SECONDARY outcome
Timeframe: 5 daysPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 daysPopulation: 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.
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.
Outcome measures
Outcome data not reported
Adverse Events
Nicotine Nasal Spray
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place