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Nicotine Patch as an Analgesic Adjuvant After Surgery

This study has been completed.
Sponsor:
Information provided by:
Columbia University
ClinicalTrials.gov Identifier:
NCT00440830
First received: February 26, 2007
Last updated: October 29, 2010
Last verified: October 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Pain
 Drug: nicotine patch
Drug: placebo
 Phase 4

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Postoperative Pain Score One Hour After Surgery [ Time Frame: 1 hour after surgery ] [ Designated as safety issue: No ]
    Postoperative pain reported after the first hour using a standard numerical rating scale (NRS) with 0=no pain and 10=worst pain imaginable.

  • Postoperative Pain Score Five Days After Surgery [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    Postoperative pain reported after five days using a standard numerical rating scale (NRS) with 0=no pain and 10=worst pain imaginable.


Secondary Outcome Measures:
  • Nausea Assessment by Patient [ Time Frame: 1 hour after surgery ] [ Designated as safety issue: No ]
    Nausea scale range: 0=none and 10=the worst, ordinal.

  • Sedation [ Time Frame: 1 hour after surgery ] [ Designated as safety issue: No ]
    Observer's Assessment of Alertness/Sedation Scale was used to report sedation.

  • Pain Medication Used [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    Pain medication used after surgery in morphine equivalents

  • Systolic Blood Pressure [ Time Frame: 1 hour after surgery ] [ Designated as safety issue: No ]
    Systolic blood pressure reported in Millimeters of Mercury (mmHg)

  • Diastolic Blood Pressure [ Time Frame: 1 hour after surgery ] [ Designated as safety issue: No ]
    Diastolic blood pressure reported in Millimeters of Mercury (mmHg)

  • Heart Rate [ Time Frame: 1 hour after surgery ] [ Designated as safety issue: No ]
    Heart rate reported in Beats per minute (BPM)


Enrollment: 68
Study Start Date: December 2005
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Smokers-nicotine
Smokers who were treated with nicotine
 Drug: nicotine patch
nicotine patch (0,5,10 or 15mg/day) applied to smokers
Other Name: nicotrol
Experimental: Nonsmokers-nicotine
Nonsmokers who were treated with nicotine
 Drug: nicotine patch
nicotine patch (0,5,10,or 15mg/day) applied to nonsmokers
Other Name: nicotrol
Placebo Comparator: Smokers-placebo
Smokers who were treated with placebo
 Drug: placebo
placebo patch applied to smokers
Placebo Comparator: Nonsmokers-placebo
Nonsmokers who were treated with placebo
 Drug: placebo
placebo patch applied to nonsmokers

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

Locations
United States, New York
New York Presbyterian
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Pamela Flood, MD Columbia University
  More Information

Publications:

Responsible Party: Pamela Flood, Columbia University
ClinicalTrials.gov Identifier: NCT00440830     History of Changes
Other Study ID Numbers: AAAB5945
Study First Received: February 26, 2007
Results First Received: October 1, 2010
Last Updated: October 29, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Columbia University:
acute pain
nicotine
nausea
sedation

Additional relevant MeSH terms:
Nicotine
Nicotine polacrilex
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
 Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 30, 2012