Nicotine as an Adjuvant Analgesic for Third Molar Surgery

Columbia University

Status and phase: Completed; Phase 4

Conditions: Dental Crowding

Treatments: Drug: Nicotine; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00385216

AAAA6273

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• over 18
• 4 molars to be removed

Exclusion criteria

• pregnant
• lactating
• chronic pain
• narcotic use
• asthma
• ex-smokers

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

Nicotine nasal spray

Active Comparator group

Description:

In one sitting the subject will receive a nicotine nasal spray, 3 mg, one application.

Treatment:

Drug: Nicotine

Placebo spray

Placebo Comparator group

Description:

In one sitting the subject will receive a placebo nasal spray (0 mg), one application.

Treatment:

Other: Placebo