- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00385216
Nicotine as an Adjuvant Analgesic for Third Molar Surgery
November 10, 2020 updated by: Columbia University
Effect of Nicotine on Pain After Third Molar Extraction.
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- Columbia University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- over 18
- 4 molars to be removed
Exclusion Criteria:
- pregnant
- lactating
- chronic pain
- narcotic use
- asthma
- ex-smokers
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Nicotine nasal spray
In one sitting the subject will receive a nicotine nasal spray, 3 mg, one application.
|
Nicotine nasal spray 3mg x 1 before surgery
Other Names:
|
Placebo Comparator: Placebo spray
In one sitting the subject will receive a placebo nasal spray (0 mg), one application.
|
Placebo nasal spray 0mg x 1 before surgery
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Reported by Patient
Time Frame: 1 day
|
Pain reported on the numerical rating scale for pain (NRS) with 0=no pain and 10=worst pain.
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nausea
Time Frame: 5 days
|
5 days
|
|
hydrocodone5 mg/Acetaminopgen 325 mg Use
Time Frame: 5 days
|
5 days
|
|
Heart Rate
Time Frame: 5 days
|
Heart rate reported in beats per minute (BPM)
|
5 days
|
Systolic Blood Pressure
Time Frame: 5 days
|
Systolic blood pressure reported in Millimeters of Mercury (mmHg)
|
5 days
|
Diastolic Blood Pressure
Time Frame: 5 days
|
Diastolic blood pressure reported in Millimeters of Mercury (mmHg)
|
5 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2004
Primary Completion (Actual)
May 1, 2009
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
October 5, 2006
First Submitted That Met QC Criteria
October 5, 2006
First Posted (Estimate)
October 9, 2006
Study Record Updates
Last Update Posted (Actual)
November 24, 2020
Last Update Submitted That Met QC Criteria
November 10, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAA6273
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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