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Completed

NCT Number: NCT00385216

Nicotine as an Adjuvant Analgesic for Third Molar Surgery

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.

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Key information

Conditions

Dental Crowding Behavior Crowding Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Spatial Behavior

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Columbia University

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • over 18
  • 4 molars to be removed

Exclusion criteria

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

Treatment and study plan

nicotine

Drug

Nicotine nasal spray 3mg x 1 before surgery

Other names: Nasal spray, nicotine

Placebo

Other

Placebo nasal spray 0mg x 1 before surgery

Other names: Nasal spray, placebo

Primary outcomes

  1. Pain Reported by Patient

    Time frame: Up to 1 day

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

Secondary outcomes

  1. Heart Rate

    Time frame: 5 days

    Heart rate reported in beats per minute (BPM)

  2. Systolic Blood Pressure

    Time frame: 5 days

    Systolic blood pressure reported in Millimeters of Mercury (mmHg)

  3. Diastolic Blood Pressure

    Time frame: 5 days

    Diastolic blood pressure reported in Millimeters of Mercury (mmHg)

  4. Difference in Amount of Nausea Reported

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

Effect of Nicotine on Pain After Third Molar Extraction.

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Oct 9, 2006
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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