The analgesic effect of parecoxib following total abdominal hysterectomy
| ISRCTN | ISRCTN47655040 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47655040 |
| Protocol serial number | N0123138268 |
| Sponsor | Department of Health |
| Funders | University Hospitals of Leicester NHS Trust (UK), Departmental funding |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
1. Morphine consumption |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/04/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 42 |
| 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
- United Kingdom
- England
Study participating centre
University Hospitals of Leicester
Leicester
LE1 4PW
United Kingdom
LE1 4PW
United Kingdom
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 | 01/06/2003 | Yes | No |
