Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smokers-nicotine | Experimental | Smokers who were treated with nicotine |
|
| Nonsmokers-nicotine | Experimental | Nonsmokers who were treated with nicotine |
|
| Smokers-placebo | Placebo Comparator | Smokers who were treated with placebo |
|
| Nonsmokers-placebo | Placebo Comparator | Nonsmokers who were treated with placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nicotine patch | Drug | nicotine patch (0,5,10 or 15mg/day) applied to smokers |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Nausea Assessment by Patient | Nausea scale range: 0=none and 10=the worst, ordinal. | 1 hour after surgery |
| Pain Medication Used | Pain medication used after surgery in morphine equivalents |
| Measure | Description | Time Frame |
|---|---|---|
| Sedation Level | Sedation may be monitored for the first hour, at the time of other data collection. | 1 hour after surgery |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pamela Flood, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Irving Medical Center / New York Presbyterian | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19923530 | Result | 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. | |
| 18713921 | Result | 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. |
Not provided
Not provided
Not provided
This prospective, double-blind trial was approved by the IRB at Columbia University Medical Center. All patients signed written informed consent before surgery.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Smokers-nicotine | Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients. |
| FG001 | Smokers-placebo | Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients. |
| FG002 | Non-smokers-nicotine | Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients. |
| FG003 | Non-smokers-placebo | Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Smokers-nicotine | Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients. |
| BG001 | Smokers-placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | 1 hour after surgery |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Smokers-nicotine | Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pamela Flood, MD | Columbia University | 212-305-2008 | pdf3@columbia.edu |
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| D059787 | Acute Pain |
| D009325 | Nausea |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
Not provided
Not provided
| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| D009538 | Nicotine |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| nicotine patch | Drug | nicotine patch (0,5,10,or 15mg/day) applied to nonsmokers |
|
|
| placebo | Drug | placebo patch applied to smokers |
|
| placebo | Drug | placebo patch applied to nonsmokers |
|
| 5 days |
| Systolic Blood Pressure | Systolic blood pressure reported in Millimeters of Mercury (mmHg) | 1 hour after surgery |
| Diastolic Blood Pressure | Diastolic blood pressure reported in Millimeters of Mercury (mmHg) | 1 hour after surgery |
| Heart Rate | Heart rate reported in Beats per minute (BPM) | 1 hour after surgery |
Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.
| BG002 | Non-smokers-nicotine | Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients. |
| BG003 | Non-smokers-placebo | Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Non-smokers-nicotine |
Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients. |
| OG003 | Non-smokers-placebo | Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients. |
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | 5 days |
|
|
|
| Secondary | Nausea Assessment by Patient | Nausea scale range: 0=none and 10=the worst, ordinal. | Posted | Mean | Standard Deviation | score on a scale | 1 hour after surgery |
|
|
|
| Secondary | Pain Medication Used | Pain medication used after surgery in morphine equivalents | Posted | Mean | Standard Deviation | Morphine equivalents | 5 days |
|
|
|
| Secondary | Systolic Blood Pressure | Systolic blood pressure reported in Millimeters of Mercury (mmHg) | Posted | Mean | Standard Deviation | Millimeters of Mercury (mmHg) | 1 hour after surgery |
|
|
|
| Secondary | Diastolic Blood Pressure | Diastolic blood pressure reported in Millimeters of Mercury (mmHg) | Posted | Mean | Standard Deviation | Millimeters of Mercury (mmHg) | 1 hour after surgery |
|
|
|
| Secondary | Heart Rate | Heart rate reported in Beats per minute (BPM) | Posted | Mean | Standard Deviation | Beats per minute (BPM) | 1 hour after surgery |
|
|
|
| Other Pre-specified | Sedation Level | Sedation may be monitored for the first hour, at the time of other data collection. | Data was not collected or analyzed for this measure. | Posted | 1 hour after surgery |
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Smokers-placebo | Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients. | 0 | 8 | 0 | 8 |
| EG002 | Non-smokers-nicotine | Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients. | 0 | 30 | 0 | 30 |
| EG003 | Non-smokers-placebo | Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients. | 0 | 10 | 0 | 10 |
Not provided
Not provided
Not provided
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |