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| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Condition: |
Pain |
| Interventions: |
Drug: Gabapentin Drug: Diphenhydramine |
Participant Flow
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| Description | |
|---|---|
| Gabapentin Preoperatively | Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery. |
| Active Placebo | Diphenhydramine 12.5 mg p.o. 2 hours preoperatively. |
| Gabapentin Preoperatively | Active Placebo | |
|---|---|---|
| STARTED | 72 | 74 |
| COMPLETED | 57 | 63 |
| NOT COMPLETED | 15 | 11 |
Baseline Characteristics
| Description | |
|---|---|
| Gabapentin Preoperatively | Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery. |
| Active Placebo | Diphenhydramine 12.5 mg p.o. 2 hours preoperatively. |
| Gabapentin Preoperatively | Active Placebo | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
72 | 74 | 146 |
|
Age
[units: participants] |
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| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 33 | 38 | 71 |
| >=65 years | 39 | 36 | 75 |
|
Age
[units: years] Mean ± Standard Deviation |
64 ± 7 | 64 ± 7 | 64 ± 7 |
|
Gender
[units: participants] |
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| Female | 32 | 38 | 70 |
| Male | 40 | 36 | 76 |
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Region of Enrollment
[units: participants] |
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| United States | 72 | 74 | 146 |
Outcome Measures
| 1. Primary: | Average Pain Score at Rest [ Time Frame: 48 hours ] |
| 2. Primary: | Average Pain Score With Coughing the First Morning Following Surgery [ Time Frame: First morning following surgery ] |
| 3. Primary: | Average Pain Score With Coughing on Second Morning After Surgery [ Time Frame: Second morning after surgery ] |
| 4. Secondary: | Opioid Consumption in First 24 Hours Postoperatively [ Time Frame: 24 hours ] |
| 5. Secondary: | Number of Participants With Pain at Thoracotomy Site 3 Months Postoperatively [ Time Frame: 3 months postoperatively ] |
| 6. Secondary: | Opioid Consumption in Second 24 Hour Hour Period (Hours 24-48) Postoperatively [ Time Frame: 48 hours postoperatively ] |
More Information
| All Principal Investigators ARE employed by the organization sponsoring the study. |
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
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| Responsible Party: | Michelle Kinney, Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00588159 History of Changes |
| Other Study ID Numbers: | 05-004145 |
| Study First Received: | December 18, 2007 |
| Results First Received: | December 28, 2010 |
| Last Updated: | August 24, 2011 |
| Health Authority: | United States: Institutional Review Board |