Condition category
Signs and Symptoms
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
14/04/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr A Ng

ORCID ID

Contact details

University Hospitals of Leicester
University Hospitals of Leicester
c/o Research and Development Office
Leicester General Hospital NHS Trust
Leicester
LE1 4PW
United Kingdom

Additional identifiers

EudraCT 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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial 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

Phase

Not Specified

Drug names

Primary outcome measures

1. Morphine consumption
2. Pain
3. Sedation
4. Nausea

Secondary outcome measures

Not provided at time of registration

Overall trial start date

15/05/2002

Overall trial end date

01/04/2003

Reason abandoned

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

Patient

Age group

Adult

Gender

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

United Kingdom

Trial 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

http://www.dh.gov.uk/Home/fs/en

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/12765890

Publication citations

  1. Results

    Ng A, Smith G, Davidson AC, Analgesic effects of parecoxib following total abdominal hysterectomy., Br J Anaesth, 2003, 90, 6, 746-749.

Additional files

Editorial Notes