Effect of Parecoxib on Post-craniotomy Pain

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Melbourne Health
• Treatments: Parecoxib

Criteria

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