Nicotine as an Adjuvant Analgesic for Third Molar Surgery

• Sponsor: Columbia University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00385216
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 59
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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: Jul 1, 2004
• Actual Primary Completion Date: May 1, 2009
• Actual Study Completion Date: Jun 1, 2009

Arms and Interventions

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 Names: 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 Names: Nasal spray, placebo

Outcome Measures

Primary Outcome Measures

1. Pain Reported by Patient [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 [5 days]

2. hydrocodone5 mg/Acetaminopgen 325 mg Use [5 days]

3. Heart Rate [5 days]

   Heart rate reported in beats per minute (BPM)

4. Systolic Blood Pressure [5 days]

   Systolic blood pressure reported in Millimeters of Mercury (mmHg)

5. Diastolic Blood Pressure [5 days]

   Diastolic blood pressure reported in Millimeters of Mercury (mmHg)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• over 18

• 4 molars to be removed

Exclusion Criteria:

• pregnant

• lactating

• chronic pain

• narcotic use

• asthma

• ex-smokers

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Columbia University	New York	New York	United States	10032

Sponsors and Collaborators

• Columbia University

Investigators

• Principal Investigator: Pamela Flood, MD, Columbia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Columbia University
• ClinicalTrials.gov Identifier: NCT00385216
• Other Study ID Numbers: AAAA6273
• First Posted: Oct 9, 2006
• Last Update Posted: Nov 24, 2020
• Last Verified: Nov 1, 2020

• Keywords provided by Columbia University: Third Molar; Pain
• Additional relevant MeSH terms: Nicotine

Study Results

Participant Flow

Arm/Group Title	Nicotine Nasal Spray First, Then Placebo	Placebo Spray First, Then Nicotine
Arm/Group Description	At the first intervention, the subject will receive a nicotine nasal spray, 3 mg, one application. At the second intervention, the subject will receive a placebo nasal spray, 0 mg, one application.	At the first intervention, the subject will receive a placebo nasal spray, 0 mg, one application. At the second intervention, the subject will receive a nicotine nasal spray, 3 mg, one application.
Period Title: First Intervention
STARTED	11	9
COMPLETED	11	9
NOT COMPLETED	0	0
Period Title: First Intervention
STARTED	11	9
COMPLETED	11	9
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Entire Study Population
Arm/Group Description	The baseline characteristics for the entire study population are presented here. The nicotine and placebo study populations were identical.
Overall Participants	20
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	20 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	23 (5)
Sex: Female, Male (Count of Participants)
Female	11 55%
Male	9 45%
Region of Enrollment (participants) [Number]
United States	20 100%

Outcome Measures

1. Primary Outcome

Title	Pain Reported by Patient
Description	Pain reported on the numerical rating scale for pain (NRS) with 0=no pain and 10=worst pain.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Nicotine Nasal Spray	Placebo
Arm/Group Description	Nicotine nasal spray (3mg) was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.	Sterile saline placebo was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
Measure Participants	20	20
Mean (Standard Deviation) [Numeric Rating Scale (NRS)]	1.6 (0.5)	2.9 (0.5)

2. Secondary Outcome

Title	Nausea
Time Frame	5 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	hydrocodone5 mg/Acetaminopgen 325 mg Use
Time Frame	5 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Heart Rate
Description	Heart rate reported in beats per minute (BPM)
Time Frame	5 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Nicotine Nasal Spray	Placebo
Arm/Group Description	Nicotine nasal spray (3mg) was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.	Sterile saline placebo was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
Measure Participants	20	20
Mean (Standard Deviation) [Beats per minute (BPM)]	81 (15)	76 (15)

5. Secondary Outcome

Title	Systolic Blood Pressure
Description	Systolic blood pressure reported in Millimeters of Mercury (mmHg)
Time Frame	5 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Nicotine Nasal Spray	Placebo
Arm/Group Description	Nicotine nasal spray (3mg) was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.	Sterile saline placebo was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
Measure Participants	20	20
Mean (Standard Deviation) [Millimeters of Mercury (mmHg)]	120 (11)	121 (12)

6. Secondary Outcome

Title	Diastolic Blood Pressure
Description	Diastolic blood pressure reported in Millimeters of Mercury (mmHg)
Time Frame	5 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Nicotine Nasal Spray	Placebo
Arm/Group Description	Nicotine nasal spray (3mg) was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.	Sterile saline placebo was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
Measure Participants	20	20
Mean (Standard Deviation) [Millimeters of Mercury (mmHg)]	77 (8)	76 (10)

Adverse Events

Arm/Group Title	Nicotine Nasal Spray		Placebo
Arm/Group Description	Nicotine nasal spray (3mg) was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.		Sterile saline nasal spray was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
All Cause Mortality
	Nicotine Nasal Spray		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Nicotine Nasal Spray		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Nicotine Nasal Spray		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)

Limitations/Caveats

This was a small study under typical clinical conditions.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.