CompletedPhase 4

Effect of Parecoxib on Post-craniotomy Pain

Australia130 participantsStarted 2006-09

Plain-language summary

Aim of this trial: To investigate whether post-craniotomy analgesia with (i) intravenous (IV) parecoxib plus intravenous paracetamol is superior to (ii) intravenous paracetamol alone. Study Hypothesis: Post-operative analgesia with intravenous parecoxib in combination with intravenous paracetamol will be superior to intravenous paracetamol alone.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Supratentorial craniotomy, glasgow coma scale 15 Exclusion Criteria: * Chronic pain, * Chronic opioid use. * History of significant alcohol or benzodiazepine (BZD) use, * Inability to speak English, * Pre-operative aphasia or dysphasia, * Renal impairment (Creatinine level \> 0.1), * Asthma (or evidence of reversible airway obstruction, * Known ischaemic heart disease or cerebrovascular disease, * American Society of Anaesthesiologists (ASA) grade IV or V, * Allergy to any study drug (paracetamol, parecoxib, sulphas, morphine, bupivacaine, propofol, remifentanil; * Administration of oral paracetamol within previous 8 hours. * Pregnancy or breastfeeding

What they're measuring

Morphine consumption in 24 hour period.

Timeframe: 24 hours after surgery

Trial details

NCT IDNCT00455117

SponsorMelbourne Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2008-12

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