Status:
COMPLETED
Effect of Parecoxib on Post-craniotomy Pain
Lead Sponsor:
Melbourne Health
Conditions:
Anaesthesia
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 Hypothes...
Detailed Description
Neurosurgical patients undergoing brain procedures (craniotomy patients) are known to suffer moderately severe postoperative pain and high rates of post-operative nausea and vomiting. Post-craniotomy ...
Eligibility Criteria
Inclusion
- Supratentorial craniotomy, glasgow coma scale 15
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00455117
Start Date
September 1 2006
End Date
December 1 2008
Last Update
May 30 2013
Active Locations (1)
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1
Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3050