A randomized, placebo controlled, trial of preoperative sustained release betamethasone plus non-controlled intraoperative ketorolac or fentanyl on pain after diagnostic laparoscopy or laparoscopic tubal ligation
| ISRCTN | ISRCTN52633712 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52633712 |
| Protocol serial number | Betamethasone ARF#1212 |
| Sponsor | University of Tennessee Anesthesiology Research Fund (USA) |
| Funder | University of Tennessee Anesthesiology Research Fund (USA) |
- Submission date
- 18/08/2003
- Registration date
- 19/08/2003
- Last edited
- 05/09/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Roger Carroll
Scientific
Scientific
UT Graduate School of Medicine
Department of Anesthesiology
1924 Alcoa Highway
Knoxville
37920
United States of America
| Phone | +1 865 544 9469 |
|---|---|
| rccarrol@mc.utmck.edu |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Postoperative pain |
| Intervention | Sustained release betamethasone versus placebo. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Betamethasone, ketorolac, fentanyl |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 74 |
| Key inclusion criteria | Patients undergoing laparoscopic surgery at University of Tennessee Medical Centre Knoxville, Tennessee (USA) |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2002 |
| Date of final enrolment | 31/12/2002 |
Locations
Countries of recruitment
- United States of America
Study participating centre
UT Graduate School of Medicine
Knoxville
37920
United States of America
37920
United States of America
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 21/08/2003 | Yes | No |
