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Nicotine Patch as an Analgesic Adjuvant After Surgery

This study has been completed.
Information provided by:
Columbia University Identifier:
First received: February 26, 2007
Last updated: October 29, 2010
Last verified: October 2010
Effect of nicotine patch as an adjutant for acute pain after surgery.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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:

Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Postoperative Pain Score One Hour After Surgery [ Time Frame: 1 hour after surgery ]
    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 ]
    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 ]
    Nausea scale range: 0=none and 10=the worst, ordinal.

  • Sedation [ Time Frame: 1 hour after surgery ]
    Observer's Assessment of Alertness/Sedation Scale was used to report sedation.

  • Pain Medication Used [ Time Frame: 5 days ]
    Pain medication used after surgery in morphine equivalents

  • Systolic Blood Pressure [ Time Frame: 1 hour after surgery ]
    Systolic blood pressure reported in Millimeters of Mercury (mmHg)

  • Diastolic Blood Pressure [ Time Frame: 1 hour after surgery ]
    Diastolic blood pressure reported in Millimeters of Mercury (mmHg)

  • Heart Rate [ Time Frame: 1 hour after surgery ]
    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.

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult ASA 1-2

Exclusion Criteria:

  • Cardiovascular disease
  • Former smoker
  • Pregnant
  • Nursing
  • Asthma
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00440830

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

Responsible Party: Pamela Flood, Columbia University 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

Keywords provided by Columbia University:
acute pain

Additional relevant MeSH terms:
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017