Nicotine Patch as an Analgesic Adjuvant After Surgery

NCT ID: NCT00440830

Last Updated: 2021-10-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2008-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Smokers-nicotine

Smokers who were treated with nicotine

Group Type EXPERIMENTAL

nicotine patch

Intervention Type DRUG

nicotine patch (0,5,10 or 15mg/day) applied to smokers

Nonsmokers-nicotine

Nonsmokers who were treated with nicotine

Group Type EXPERIMENTAL

nicotine patch

Intervention Type DRUG

nicotine patch (0,5,10,or 15mg/day) applied to nonsmokers

Smokers-placebo

Smokers who were treated with placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo patch applied to smokers

Nonsmokers-placebo

Nonsmokers who were treated with placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo patch applied to nonsmokers

Interventions

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nicotine patch

nicotine patch (0,5,10 or 15mg/day) applied to smokers

Intervention Type DRUG

nicotine patch

nicotine patch (0,5,10,or 15mg/day) applied to nonsmokers

Intervention Type DRUG

placebo

placebo patch applied to smokers

Intervention Type DRUG

placebo

placebo patch applied to nonsmokers

Intervention Type DRUG

Other Intervention Names

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nicotrol nicotrol

Eligibility Criteria

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Inclusion Criteria

* Adult ASA 1-2

Exclusion Criteria

* Cardiovascular disease
* Former smoker
* Pregnant
* Nursing
* Asthma
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Columbia University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pamela Flood, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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Columbia University Irving Medical Center / New York Presbyterian

New York, New York, United States

Site Status

Countries

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United States

References

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Olson LC, Hong D, Conell-Price JS, Cheng S, Flood P. A transdermal nicotine patch is not effective for postoperative pain management in smokers: a pilot dose-ranging study. Anesth Analg. 2009 Dec;109(6):1987-91. doi: 10.1213/ANE.0b013e3181bd1612.

Reference Type RESULT
PMID: 19923530 (View on PubMed)

Hong D, Conell-Price J, Cheng S, Flood P. Transdermal nicotine patch for postoperative pain management: a pilot dose-ranging study. Anesth Analg. 2008 Sep;107(3):1005-10. doi: 10.1213/ane.0b013e318163204f.

Reference Type RESULT
PMID: 18713921 (View on PubMed)

Other Identifiers

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AAAB5945

Identifier Type: -

Identifier Source: org_study_id