Nicotine as an Adjuvant Analgesic for Third Molar Surgery

Dental Crowding Clinical Trial

Official title:

Effect of Nicotine on Pain After Third Molar Extraction.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00385216
• Other study ID #: AAAA6273
• Status: Completed
• Phase: Phase 4
• Start date: July 2004
• Est. completion date: June 2009

Study information

• Verified date: November 2020
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• over 18

• 4 molars to be removed

Exclusion Criteria:

• pregnant

• lactating

• chronic pain

• narcotic use

• asthma

• ex-smokers

Related Conditions & MeSH terms

• Dental Crowding

Intervention

Drug:
• Nicotine
Nicotine nasal spray 3mg x 1 before surgery

Other:
• Placebo
Placebo nasal spray 0mg x 1 before surgery

Locations

Country	Name	City	State
United States	Columbia University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Reported by Patient	Pain reported on the numerical rating scale for pain (NRS) with 0=no pain and 10=worst pain.	1 day
Secondary	Nausea		5 days
Secondary	hydrocodone5 mg/Acetaminopgen 325 mg Use		5 days
Secondary	Heart Rate	Heart rate reported in beats per minute (BPM)	5 days
Secondary	Systolic Blood Pressure	Systolic blood pressure reported in Millimeters of Mercury (mmHg)	5 days
Secondary	Diastolic Blood Pressure	Diastolic blood pressure reported in Millimeters of Mercury (mmHg)	5 days