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

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 Salicylsalicylic acid Sodium salicylate

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
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

Salicylsalicylic acid

Sodium Salicylate

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 October 29, 2008

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