Nicotine as an Adjuvant Analgesic for Third Molar Surgery

NCT ID: NCT00385216

Last Updated: 2024-09-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2009-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Dental Crowding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Nicotine nasal spray

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

Group Type ACTIVE_COMPARATOR

Nicotine

Intervention Type DRUG

Nicotine nasal spray 3mg x 1 before surgery

Placebo spray

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo nasal spray 0mg x 1 before surgery

Interventions

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Nicotine

Nicotine nasal spray 3mg x 1 before surgery

Intervention Type DRUG

Placebo

Placebo nasal spray 0mg x 1 before surgery

Intervention Type OTHER

Other Intervention Names

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Nasal spray, nicotine Nasal spray, placebo

Eligibility Criteria

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Inclusion Criteria

* over 18
* 4 molars to be removed

Exclusion Criteria

* pregnant
* lactating
* chronic pain
* narcotic use
* asthma
* ex-smokers
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Columbia University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pamela Flood, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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Columbia University

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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AAAA6273

Identifier Type: -

Identifier Source: org_study_id

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