Nicotine Patch as an Analgesic Adjuvant After Surgery - Full Text View

Sponsored by:	Columbia University
Information provided by:	Columbia University
ClinicalTrials.gov Identifier:	NCT00440830

Purpose

Effect of nicotine patch as an adjutant for acute pain after surgery.

Condition	Intervention	Phase
Pain	Drug: nicotine patch	Phase IV

MedlinePlus related topics: Nausea and Vomiting

Drug Information available for: Nicotine polacrilex Nicotine tartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Study to Determine Whether the Use of a Nicotine Patch During the Day of Surgery Improves Postoperative Pain and Reduces Opioid Requirement.

Further study details as provided by Columbia University:

Primary Outcome Measures:

VAS [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

morphine utilization, sedation, nausea, hemodynamics [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	December 2005
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 smokers	Drug: nicotine patch nicotine patch (0,5,10 or 15mg/day) Drug: nicotine patch nicotine patch (0,5,10,or 15mg/day)
2 non-smokers	Drug: nicotine patch nicotine patch (0,5,10 or 15mg/day) Drug: nicotine patch nicotine patch (0,5,10,or 15mg/day)

Detailed Description:

This is a dose finding trial for nicotine patches as analgesics. Doses used are 5mg/ 10mg/ 15mg or placebo. Primary outcome variable is reported pain score (VAS), secondary is morphine PCA utilization, nausea, sedation, and hemodynamic changes.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adult ASA 1-2

Exclusion Criteria:

Cardiovascular disease
Former smoker
Pregnant
Nursing
Asthma

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00440830

Contacts

Contact: Pamela Flood, MD

212-305-2008

pdf3@columbia.edu

Locations

United States, New York
New York Presbyterian	Recruiting
New York, New York, United States, 10032
Principal Investigator: Pamela Flood, MD

Sponsors and Collaborators

Columbia University

Investigators

Principal Investigator:

Pamela Flood, MD

Columbia University

More Information

Responsible Party:	Columbia University ( Pamela Flood )
Study ID Numbers:	AAAB5945
Study First Received:	February 26, 2007
Last Updated:	July 21, 2008
ClinicalTrials.gov Identifier:	NCT00440830
Health Authority:	United States: Food and Drug Administration

Keywords provided by Columbia University:

acute pain
nicotine
nausea
sedation

Study placed in the following topic categories:

Nicotine polacrilex
Nicotine
Nausea
Pain
Pain, Postoperative

Additional relevant MeSH terms:

Neurotransmitter Agents
Cholinergic Agonists
Molecular Mechanisms of Pharmacological Action
Nicotinic Agonists
Physiological Effects of Drugs
Central Nervous System Stimulants
Cholinergic Agents

Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Ganglionic Stimulants
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009