Nicotine Patch as an Analgesic Adjuvant After Surgery

Columbia University

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Drug: placebo; Drug: nicotine patch

Study type: Interventional

Funder types: Other

Identifiers

NCT00440830

AAAB5945

Details and patient eligibility

About

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

Full 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.

Enrollment: 68 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult ASA 1-2

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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68 participants in 4 patient groups, including a placebo group

Smokers-nicotine

Experimental group

Description:

Smokers who were treated with nicotine

Treatment:

Drug: nicotine patch

Drug: nicotine patch

Nonsmokers-nicotine

Experimental group

Description:

Nonsmokers who were treated with nicotine

Treatment:

Drug: nicotine patch

Drug: nicotine patch

Smokers-placebo

Placebo Comparator group

Description:

Smokers who were treated with placebo

Treatment:

Drug: placebo

Drug: placebo

Nonsmokers-placebo

Placebo Comparator group

Description:

Nonsmokers who were treated with placebo

Treatment:

Drug: placebo

Drug: placebo