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Nicotine as an Adjuvant Analgesic for Third Molar Surgery

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ClinicalTrials.gov Identifier: NCT00385216
Recruitment Status : Completed
First Posted : October 9, 2006
Results First Posted : October 27, 2010
Last Update Posted : December 17, 2010
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Dental Crowding Drug: Nicotine Other: Placebo Phase 4

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  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Nicotine on Pain After Third Molar Extraction.
Study Start Date : July 2004
Actual Primary Completion Date : May 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Nicotine nasal spray
In one sitting the subject will receive a nicotine nasal spray, 3 mg, one application.
Drug: Nicotine
Nicotine nasal spray 3mg x 1 before surgery
Other Name: Nasal spray, nicotine

Placebo Comparator: Placebo spray
In one sitting the subject will receive a placebo nasal spray (0 mg), one application.
Other: Placebo
Placebo nasal spray 0mg x 1 before surgery
Other Name: Nasal spray, placebo




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Nausea [ Time Frame: 5 days ]
  2. hydrocodone5 mg/Acetaminopgen 325 mg Use [ Time Frame: 5 days ]
  3. Heart Rate [ Time Frame: 5 days ]
    Heart rate reported in beats per minute (BPM)

  4. Systolic Blood Pressure [ Time Frame: 5 days ]
    Systolic blood pressure reported in Millimeters of Mercury (mmHg)

  5. Diastolic Blood Pressure [ Time Frame: 5 days ]
    Diastolic blood pressure reported in Millimeters of Mercury (mmHg)



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • over 18
  • 4 molars to be removed

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00385216


Locations
United States, New York
Columbia University
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Pamela Flood, MD Columbia University

Responsible Party: Pamela Flood, Columbia University
ClinicalTrials.gov Identifier: NCT00385216     History of Changes
Other Study ID Numbers: AAAA6273
First Posted: October 9, 2006    Key Record Dates
Results First Posted: October 27, 2010
Last Update Posted: December 17, 2010
Last Verified: December 2010

Keywords provided by Columbia University:
Third Molar
Pain

Additional relevant MeSH terms:
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action