Nicotine as an Adjuvant Analgesic for Third Molar Surgery

Phase 4

Completed

• Conditions: Dental Crowding
• Interventions: Drug: Nicotine; Other: Placebo

• Registration Number: NCT00385216
• Lead Sponsor: Columbia University

Brief 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.

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 Timeline

• Study Start: 2004-07
• Study First Submitted: 2006-10-05
• Study First Submitted QC: 2006-10-05
• Study First Posted: 2006-10-09
• Primary Completion: 2009-05
• Study Completion: 2009-06
• Results First Submitted: 2010-10-01
• Results First Submitted QC: 2010-10-01
• Results First Posted: 2010-10-27
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-10
• Last Update Posted: 2020-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• over 18
• 4 molars to be removed

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nicotine nasal spray	Nicotine	In one sitting the subject will receive a nicotine nasal spray, 3 mg, one application.
Placebo spray	Placebo	In one sitting the subject will receive a placebo nasal spray (0 mg), one application.

Primary Outcome Measures

Name	Time	Method
Pain Reported by Patient	Up to 1 day	Pain were reported on the numerical rating scale for pain (NRS) with 0=no pain and 10=worst pain.

Secondary Outcome Measures

Name	Time	Method
Heart Rate	5 days	Heart rate reported in beats per minute (BPM)
Systolic Blood Pressure	5 days	Systolic blood pressure reported in Millimeters of Mercury (mmHg)
Diastolic Blood Pressure	5 days	Diastolic blood pressure reported in Millimeters of Mercury (mmHg)
Difference in Amount of Nausea Reported	5 days	For an hour postoperatively, subjects reported information on pain and nausea, and hemodynamic variables were recorded at 15-minute intervals. Telephone follow-up was recorded for 5 days postoperatively, where patients reported information on pain, nausea, and use of hydrocodone/acetaminophen as rescue analgesia.
Difference in Number of Hydrocodone 5 mg Acetaminophen 325 mg Tablets Taken After Surgery	5 days	All patients were prescribed Hydrocodone 5 mg / Acetaminophen 325 mg and were instructed to take 1 to 2 tablets for oral pain at a maximum of every 4 to 6 hours post-surgery.

Trial Locations

Locations (1)

Columbia University; 🇺🇸 New York, New York, United States