NCT00440830

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for phase_4 pain

Timeline
Completed

Started Dec 2005

Longer than P75 for phase_4 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 27, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

October 27, 2010

Completed
Last Updated

October 21, 2021

Status Verified

September 1, 2021

Enrollment Period

3 years

First QC Date

February 26, 2007

Results QC Date

October 1, 2010

Last Update Submit

September 27, 2021

Conditions

Pain

Keywords

acute painnicotinenauseasedation

Outcome Measures

Primary Outcomes (2)

  • Postoperative Pain Score One 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.

    1 hour after surgery

  • Postoperative Pain Score Five Days After Surgery

    Postoperative pain reported after five days using a standard numerical rating scale (NRS) with 0=no pain and 10=worst pain imaginable.

    5 days

Secondary Outcomes (5)

  • Nausea Assessment by Patient

    1 hour after surgery

  • Pain Medication Used

    5 days

  • Systolic Blood Pressure

    1 hour after surgery

  • Diastolic Blood Pressure

    1 hour after surgery

  • Heart Rate

    1 hour after surgery

Other Outcomes (1)

  • Sedation Level

    1 hour after surgery

Study Arms (4)

Smokers-nicotine

EXPERIMENTAL

Smokers who were treated with nicotine

Drug: nicotine patch

Nonsmokers-nicotine

EXPERIMENTAL

Nonsmokers who were treated with nicotine

Drug: nicotine patch

Smokers-placebo

PLACEBO COMPARATOR

Smokers who were treated with placebo

Drug: placebo

Nonsmokers-placebo

PLACEBO COMPARATOR

Nonsmokers who were treated with placebo

Drug: placebo

Interventions

nicotine patchDRUG

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

Also known as: nicotrol
Smokers-nicotine
placeboDRUG

placebo patch applied to smokers

Smokers-placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adult ASA 1-2

You may not qualify if:

  • Cardiovascular disease
  • Former smoker
  • Pregnant
  • Nursing
  • Asthma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Irving Medical Center / New York Presbyterian

New York, New York, 10032, United States

Location

Related Publications (2)

  • 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.

    PMID: 19923530RESULT

  • 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.

    PMID: 18713921RESULT

MeSH Terms

Conditions

PainAcute PainNausea

Interventions

Tobacco Use Cessation DevicesNicotine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

TherapeuticsSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Results Point of Contact

Title
Pamela Flood, MD
Organization
Columbia University
pdf3@columbia.edu
212-305-2008

Study Officials

  • Pamela Flood, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2007

First Posted

February 27, 2007

Study Start

December 1, 2005

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

October 21, 2021

Results First Posted

October 27, 2010

Record last verified: 2021-09

Locations

US(1)