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

February 26, 2007
October 29, 2010
December 2005
December 2008   (final data collection date for primary outcome measure)
  • 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.
VAS
Complete list of historical versions of study NCT00440830 on ClinicalTrials.gov Archive Site
  • 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)
morphine utilization, sedation, nausea, hemodynamics
Not Provided
Not Provided
 
Nicotine Patch as an Analgesic Adjuvant After Surgery
Study to Determine Whether the Use of a Nicotine Patch During the Day of Surgery Improves Postoperative Pain and Reduces Opioid Requirement.

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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pain
  • Drug: nicotine patch
    nicotine patch (0,5,10 or 15mg/day) applied to smokers
    Other Name: nicotrol
  • Drug: nicotine patch
    nicotine patch (0,5,10,or 15mg/day) applied to nonsmokers
    Other Name: nicotrol
  • Drug: placebo
    placebo patch applied to smokers
  • Drug: placebo
    placebo patch applied to nonsmokers
  • Experimental: Smokers-nicotine
    Smokers who were treated with nicotine
    Intervention: Drug: nicotine patch
  • Experimental: Nonsmokers-nicotine
    Nonsmokers who were treated with nicotine
    Intervention: Drug: nicotine patch
  • Placebo Comparator: Smokers-placebo
    Smokers who were treated with placebo
    Intervention: Drug: placebo
  • Placebo Comparator: Nonsmokers-placebo
    Nonsmokers who were treated with placebo
    Intervention: Drug: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
68
December 2008
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult ASA 1-2

Exclusion Criteria:

  • Cardiovascular disease
  • Former smoker
  • Pregnant
  • Nursing
  • Asthma
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00440830
AAAB5945
No
Pamela Flood, Columbia University
Columbia University
Not Provided
Principal Investigator: Pamela Flood, MD Columbia University
Columbia University
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP