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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00385216
Other study ID # AAAA6273
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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