Phase 4
N=20
Nicotine as an Adjuvant Analgesic for Third Molar Surgery
Dental Crowding
Bottom Line
View on ClinicalTrials.gov: NCT00385216 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Oct 2010
Primary outcome: Primary: Pain Reported by Patient — 1.6; 2.9 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Nicotine (Drug); Placebo (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Reported by Patient |
1.6; 2.9 | — |
| SECONDARY Heart Rate |
81; 76 | — |
| SECONDARY Systolic Blood Pressure |
120; 121 | — |
| SECONDARY Diastolic Blood Pressure |
77; 76 | — |
| SECONDARY Difference in Amount of Nausea Reported |
— | — |
| SECONDARY Difference in Number of Hydrocodone 5 mg Acetaminophen 325 mg Tablets Taken After Surgery |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- over 18
- 4 molars to be removed
Exclusion Criteria
- pregnant
- lactating
- chronic pain
- narcotic use
- asthma
- ex-smokers
Data sourced from ClinicalTrials.gov (NCT00385216). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.