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

Status

Completed

Conditions

Intervention / Treatment

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:
  • Nasal spray, nicotine
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:
  • Nasal spray, placebo

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.

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

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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