Effect of Parecoxib on Post-craniotomy Pain
Phase Four Study of Intravenous Parecoxib on Post-craniotomy Pain
1 other identifier
interventional
130
1 country
1
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 Hypothesis: Post-operative analgesia with intravenous parecoxib in combination with intravenous paracetamol will be superior to intravenous paracetamol alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Sep 2006
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 1, 2007
CompletedFirst Posted
Study publicly available on registry
April 3, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedMay 30, 2013
May 1, 2013
2.3 years
April 1, 2007
May 28, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Morphine consumption in 24 hour period.
24 hours after surgery
Secondary Outcomes (10)
Immediate post-operative hypertension (first 2 hours)
24 hours after surgery
Pain scores at zero (time of extubation), 1, 2, 4, 12, 24 hours post operatively
24 hours after surgery
Analgesic efficacy at 24 hours
24 hours after surgery
Incidence of post-operative nausea and vomiting (first 24 hours)
24 hours after surgery
Sedation or respiratory depression (first 24 hours)
24 hours after surgery
- +5 more secondary outcomes
Study Arms (2)
1
PLACEBO COMPARATORplacebo (2 ml normal saline) administered intravenously at dural closure during craniotomy
2
ACTIVE COMPARATORparecoxib 40 mg in 2 ml normal saline administered intravenously at dural closure during craniotomy
Interventions
parecoxib or placebo
Eligibility Criteria
You may qualify if:
- Supratentorial craniotomy, glasgow coma scale 15
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Melbourne Healthlead
Study Sites (1)
Royal Melbourne Hospital
Melbourne, Victoria, 3050, Australia
Related Publications (1)
Williams DL, Pemberton E, Leslie K. Effect of intravenous parecoxib on post-craniotomy pain. Br J Anaesth. 2011 Sep;107(3):398-403. doi: 10.1093/bja/aer223.
PMID: 21841050DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daryl L Williams, MBBS
Director of Anaesthesia, Royal Melbourne Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2007
First Posted
April 3, 2007
Study Start
September 1, 2006
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
May 30, 2013
Record last verified: 2013-05