Nicotine as an Adjuvant Analgesic for Third Molar Surgery
Effect of Nicotine on Pain After Third Molar Extraction.
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jul 2004
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 5, 2006
CompletedFirst Posted
Study publicly available on registry
October 9, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedResults Posted
Study results publicly available
October 27, 2010
CompletedSeptember 19, 2024
September 1, 2024
4.8 years
October 5, 2006
October 1, 2010
September 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain Reported by Patient
Pain were reported on the numerical rating scale for pain (NRS) with 0=no pain and 10=worst pain.
Up to 1 day
Secondary Outcomes (5)
Heart Rate
5 days
Systolic Blood Pressure
5 days
Diastolic Blood Pressure
5 days
Difference in Amount of Nausea Reported
5 days
Difference in Number of Hydrocodone 5 mg Acetaminophen 325 mg Tablets Taken After Surgery
5 days
Study Arms (2)
Nicotine nasal spray
ACTIVE COMPARATORIn one sitting the subject will receive a nicotine nasal spray, 3 mg, one application.
Placebo spray
PLACEBO COMPARATORIn one sitting the subject will receive a placebo nasal spray (0 mg), one application.
Interventions
Eligibility Criteria
You may qualify if:
- over 18
- molars to be removed
You may not qualify if:
- pregnant
- lactating
- chronic pain
- narcotic use
- asthma
- ex-smokers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Columbia University
New York, New York, 10032, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pamela Flood, MD
- Organization
- Columbia University
Study Officials
- PRINCIPAL INVESTIGATOR
Pamela Flood, MD
Columbia University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2006
First Posted
October 9, 2006
Study Start
July 1, 2004
Primary Completion
May 1, 2009
Study Completion
June 1, 2009
Last Updated
September 19, 2024
Results First Posted
October 27, 2010
Record last verified: 2024-09