Nicotine as an Adjuvant Analgesic for Third Molar Surgery

Columbia University20 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Dental Crowding

Interventions

NicotineDRUG

Nicotine nasal spray 3mg x 1 before surgery

PlaceboOTHER

Placebo nasal spray 0mg x 1 before surgery

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * over 18 * 4 molars to be removed Exclusion Criteria: * pregnant * lactating * chronic pain * narcotic use * asthma * ex-smokers

Locations (1)

Columbia University

New York, New York, United States

Outcomes

Primary Outcomes

Pain Reported by Patient

Pain were reported on the numerical rating scale for pain (NRS) with 0=no pain and 10=worst pain.

Time frame: Up to 1 day

Secondary Outcomes

Heart Rate

Heart rate reported in beats per minute (BPM)

Time frame: 5 days

Systolic Blood Pressure

Systolic blood pressure reported in Millimeters of Mercury (mmHg)

Time frame: 5 days

Diastolic Blood Pressure

Diastolic blood pressure reported in Millimeters of Mercury (mmHg)

Time frame: 5 days

Difference in Amount of Nausea Reported

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.

Time frame: 5 days

Difference in Number of Hydrocodone 5 mg Acetaminophen 325 mg Tablets Taken After Surgery

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.

Time frame: 5 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.