|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Condition: |
Postoperative Pain |
| Interventions: |
Drug: Gabapentin Drug: Placebo Drug: Morphine |
Participant Flow
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| No text entered. |
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| No text entered. |
| Description | |
|---|---|
| Gabapentin/Morphine | Gabapentin - group received gabapentin 3 times daily 5 mg/kg/dose. *Both groups received Morphine as needed. |
| Placebo/Morphine | Placebo Comparator - group received placebo 3 times daily. *Both groups received Morphine as needed. |
| Gabapentin/Morphine | Placebo/Morphine | |
|---|---|---|
| STARTED | 32 | 31 |
| COMPLETED | 29 | 30 |
| NOT COMPLETED | 3 | 1 |
| Physician Decision | 0 | 1 |
| Withdrawal by Subject | 2 | 0 |
| Protocol Violation | 1 | 0 |
Baseline Characteristics
| Description | |
|---|---|
| Gabapentin/Morphine | Gabapentin - group received gabapentin 3 times daily 5 mg/kg/dose. *Both groups received Morphine as needed. |
| Placebo/Morphine | Placebo Comparator - group received placebo 3 times daily. *Both groups received Morphine as needed. |
| Gabapentin/Morphine | Placebo/Morphine | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
32 | 31 | 63 |
|
Age
[units: participants] |
|||
| <=18 years | 32 | 31 | 63 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
|
Age
[units: years] Mean ± Standard Deviation |
14.8 ± 2.1 | 14.2 ± 1.8 | 14.5 ± 2.0 |
|
Gender
[units: participants] |
|||
| Female | 23 | 24 | 47 |
| Male | 9 | 7 | 16 |
Outcome Measures
| 1. Primary: | Amount of Morphine Consumed (mg/kg/hr) [ Time Frame: PARU (Postanesthesia Recovery Unit - participants typically remain in PARU for 1 hour) ] |
| 2. Primary: | Amount of Morphine Consumed (mg/kg/hr) [ Time Frame: Day 1 ] |
| 3. Primary: | Amount of Morphine Consumed (mg/kg/hr) [ Time Frame: Day 2 ] |
| 4. Secondary: | Side Effect Occurrence [ Time Frame: First 10 days after surgery ] |
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 |
|---|
| No text entered. |
| Responsible Party: | Dr. Lynn M. Rusy, Medical College of Wisconsin Anesthesia Department |
| ClinicalTrials.gov Identifier: | NCT00726999 History of Changes |
| Other Study ID Numbers: | 06/71,GC 138 |
| Study First Received: | July 30, 2008 |
| Results First Received: | August 19, 2010 |
| Last Updated: | January 3, 2011 |
| Health Authority: | United States: Food and Drug Administration |