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

A comparison of intravenous ibuprofen 800mg, parecoxib 40mg, parecoxib 80mg and placebo in female patients undergoing hysteroscopy +/- dilatation and curettage +/- mirena insertion as day case surgery - a comparison of analgesic efficacy, quality of recovery and incidence of opioid related side effects

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613001243707

Acronym

DEFINITIVE

Enrollment

280

Registered

2013-11-13

Start date

2014-07-30

Completion date

2019-07-10

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This trial will compare three intravenous anti-inflammatory regimens against placebo in women undergoing hysteroscopy and dilatation and curettage (D&C) as a day case surgery. It will compare the effectiveness of pain relief immediately post surgery and during the subsequent 24 hours. It will also compare the incidence and severity of side effects of pain relieving drugs including nausea and itch, and overall quality of recovery from surgery using a well validated questionnaire.

Interventions

Arm 1. Intravenous ibuprofen 800mg single dose at the time of surgery Arm 2. Intravenous parecoxib 80mg single dose at the time of surgery Arm 3. Intravenous parecoxib 40mg single dose at the time of surgery

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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

Outcome results