Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N0123138268
Study information
Scientific title
Acronym
Study hypothesis
To investigate the analgesic effects and benefits of parecoxib.
Ethics approval(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study type
Not Specified
Patient information sheet
Condition
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
Overall study end date
01/04/2003
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients having total abdominal hysterectomy
2. American Society of Anesthesiologists (ASA) 1-11
3. Aged 20 - 65, female
Participant type(s)
Patient
Age group
Adult
Sex
Female
Target number of participants
21 controls/21 patients
Participant exclusion criteria
1. Patients having hysterectomy/morphine consumption
2. Pain
3. Sedation
4. Nausea
Recruitment start date
15/05/2002
Recruitment end date
01/04/2003
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
University Hospitals of Leicester
Leicester
LE1 4PW
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
University Hospitals of Leicester NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Departmental funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/06/2003 | Yes | No |