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

Tracking Information

First Received Date ^ICMJE

February 26, 2007

Last Updated Date

October 29, 2010

Start Date ^ICMJE

December 2005

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

VAS

Change History

Complete list of historical versions of study NCT00440830 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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)

Original Secondary Outcome Measures ^ICMJE

morphine utilization, sedation, nausea, hemodynamics

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Nicotine Patch as an Analgesic Adjuvant After Surgery

Official Title ^ICMJE

Study to Determine Whether the Use of a Nicotine Patch During the Day of Surgery Improves Postoperative Pain and Reduces Opioid Requirement.

Brief Summary

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Pain

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2008

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Adult ASA 1-2

Exclusion Criteria:

Cardiovascular disease
Former smoker
Pregnant
Nursing
Asthma

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00440830

Other Study ID Numbers ^ICMJE

AAAB5945

Has Data Monitoring Committee

Responsible Party

Pamela Flood, Columbia University

Study Sponsor ^ICMJE

Columbia University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Pamela Flood, MD

Columbia University

Information Provided By

Columbia University

Verification Date

October 2010

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

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