Determining the efficacy of anti-inflammatories given by the intravenous route in gynaecologic day case surgery

Not Applicable

Completed

• Conditions: Pain management following hysteroscopy +/- dilatation and curettage +/- mirena insertion; Anaesthesiology - Pain management; Reproductive Health and Childbirth - Other reproductive health and childbirth disorders

• Registration Number: ACTRN12613001243707
• Lead Sponsor: Department of Anaesthesia and Pain Medicine, King Edward Memorial Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-11-13
• Study Completion: 2019-07-11
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 280

Inclusion Criteria

ASA 1 or 2
Undergoing hysteroscopy +/- dilatation and curettage +/- mirena insertion

Exclusion Criteria

Renal dysfunction
Hypertension
Ischaemic heart disease
Cerebrovascular disease
Past or current peptic ulcer disease
Allergy to non-steroidal anti-inflammatory drugs
Aspirin or NSAID induced asthma
Hepatocellular insufficiency
Unsuitable for general anaesthesia with maintenance with inhalational agent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The efficacy of the analgesic regimen as determined by the highest pain score in the recovery room post operatively.<br><br>[Immediately post-operatively: first recovery pain score (numeric rating score 0-10)<br>];The OBAS (overall benefit of analgesia score), which assesses pain intensity and opioid-related adverse effects (score range 0-28)[24 hours post-operatively]

Secondary Outcome Measures

Name	Time	Method
The efficacy of the analgesic regimen as determined by:<br>a. Pain scores at rest and due to abdominal cramping at one hour, two hours and 24 hours post operatively<br>b. Highest pain score over the 24-hour period<br>c. Area under the curve for rest and crampy pain scores over 0-24 hours<br>[0-24hours post-operatively];Time to first rescue analgesia with fentanyl[Up to two hours post-operatively];Cumulative dose of fentanyl (intra & post operatively)[Intra-operatively and up to two hours post-operatively];Time to first dose of tramadol (oral)[24 hours];Cumulative dose of tramadol in 24hr[24 hours];Cumulative dose of paracetamol in 24hr[24 hours];The incidence of nausea and vomiting - yes/no[24 hours];The incidence of itching - yes/no[24 hours];Quality of Recovery (QoR) questionnaire[24 hours]