Parecoxib and paracetamol for pain relief following minor day stay gynaecological surgery (The PAINFREE Trial)

Phase 4

Completed

• Conditions: Postoperative analgesia after minor gynaecological surgery; Anaesthesiology - Pain management

• Registration Number: ACTRN12611000345987
• Lead Sponsor: Women's and Newborn Health Service

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-04-01
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 240

Inclusion Criteria

Dilatation and curettage
American Society of Anesthesiologists physical status 1 or 2

Exclusion Criteria

Renal dysfunction
Hypertension
Ischaemic heart disease
Cerebrovascular disease
Peptic ulcer or gastro-intestinal reflux disease
Aspirin or nonsteroidal anti-inflammatory drug induced asthma
Allergy to paracetamol, parecoxib or sulphonamides
Hepatic dysfunction
Taking analgesic drugs within 24 hours of surgery
Unsuitable for anaesthesia with volatile anaesthetics or requiring intubation
Prophylactic antiemetic therapy indicated

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
0-28 'overall benefit of analgesia score'. This is a validated, scored patient questionnaire consisting of 7 questions each with four response options. The maximum score is 28 and a low score represents high benefit.[24 hours postoperatively];0-10 verbal numerical rating pain with movement score. with a minimum value of zero and a maximum value of ten[1 hour postoperatively]

Secondary Outcome Measures

Name	Time	Method
Area under the curve pain score with movement[24 hours postoperatively];Area under the curve pain score at rest[24 hours postoperatively]