The analgesic effect of parecoxib following total abdominal hysterectomy
| ISRCTN | ISRCTN47655040 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47655040 |
| Secondary identifying numbers | N0123138268 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 14/04/2008
- 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
Dr A Ng
Scientific
Scientific
University Hospitals of Leicester
University Hospitals of Leicester
c/o Research and Development Office
Leicester General Hospital NHS Trust
Leicester
LE1 4PW
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | To investigate the analgesic effects and benefits of parecoxib. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Post-operative pain |
| Intervention | All patients were given intraoperative: 1. Propofol 2 - 4 mg kg intravenously (i.v.) 2. Morphine 10 mg i.v. 3. Prochlorperazine 12.5 mg intramuscularly (i.m.) Patients' lungs were ventilated with nitrous oxide and isoflurane 1 - 1.5% in oxygen, and morphine was self-administered for postoperative analgesia via a patient controlled analgesia (PCA) device. Patients were allocated randomly to receive either parecoxib 40 mg i.v. or normal saline on induction of anaesthesia. |
| Intervention type | Other |
| Primary outcome measure | 1. Morphine consumption 2. Pain 3. Sedation 4. Nausea |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 15/05/2002 |
| Completion date | 01/04/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 21 controls/21 patients |
| Key inclusion criteria | 1. Patients having total abdominal hysterectomy 2. American Society of Anesthesiologists (ASA) 1-11 3. Aged 20 - 65, female |
| Key exclusion criteria | 1. Patients having hysterectomy/morphine consumption 2. Pain 3. Sedation 4. Nausea |
| Date of first enrolment | 15/05/2002 |
| Date of final enrolment | 01/04/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University Hospitals of Leicester
Leicester
LE1 4PW
United Kingdom
LE1 4PW
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
University Hospitals of Leicester NHS Trust (UK)
No information available
Departmental funding
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 | 01/06/2003 | Yes | No |
