Nicotine as an Adjuvant Analgesic for Third Molar Surgery - Full Text View

Sponsored by:	Columbia University
Information provided by:	Columbia University
ClinicalTrials.gov Identifier:	NCT00385216

Purpose

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.

Condition	Intervention	Phase
Dental Crowding	Drug: Nicotine nasal spray	Phase IV

Drug Information available for: Nicotine polacrilex Nicotine tartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Effect of Nicotine on Pain After Third Molar Extraction.

Further study details as provided by Columbia University:

Primary Outcome Measures:

Pain [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

nausea [ Time Frame: 5 days ] [ Designated as safety issue: No ]
inflammation [ Time Frame: 5 days ] [ Designated as safety issue: No ]
narcotic use [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	52
Study Start Date:	July 2004
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Nicotine nasal spray 3mg x 1 before surgery

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.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

over 18
4 molars to be removed

Exclusion Criteria:

pregnant
lactating
chronic pain
narcotic use
asthma
ex-smokers

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00385216

Contacts

Contact: Pamela Flood

212-305-2008

pdf3@columbia.edu

Locations

United States, New York
Columbia University	Recruiting
New York, New York, United States, 10032

Sponsors and Collaborators

Columbia University

Investigators

Principal Investigator:

Pamela Flood, MD

Columbia University

More Information

Responsible Party:	Columbia University ( Pamela Flood )
Study ID Numbers:	AAAA6273
Study First Received:	October 5, 2006
Last Updated:	July 14, 2008
ClinicalTrials.gov Identifier:	NCT00385216
Health Authority:	United States: Food and Drug Administration

Keywords provided by Columbia University:

Third Molar
Pain

Study placed in the following topic categories:

Nicotine polacrilex
Nicotine
Pain

Additional relevant MeSH terms:

Neurotransmitter Agents
Cholinergic Agonists
Molecular Mechanisms of Pharmacological Action
Nicotinic Agonists
Physiological Effects of Drugs
Central Nervous System Stimulants
Cholinergic Agents

Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Ganglionic Stimulants
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009