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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00455117




Registration number
NCT00455117
Ethics application status
Date submitted
1/04/2007
Date registered
3/04/2007
Date last updated
30/05/2013

Titles & IDs
Public title
Effect of Parecoxib on Post-craniotomy Pain
Scientific title
Phase Four Study of Intravenous Parecoxib on Post-craniotomy Pain
Secondary ID [1] 0 0
Parecoxib_HREC2006.133
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaesthesia 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Intravenous Parecoxib ('Dynastat' Pfizer)

Placebo Comparator: 1 - placebo (2 ml normal saline) administered intravenously at dural closure during craniotomy

Active Comparator: 2 - parecoxib 40 mg in 2 ml normal saline administered intravenously at dural closure during craniotomy


Treatment: Drugs: Intravenous Parecoxib ('Dynastat' Pfizer)
parecoxib or placebo

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Morphine consumption in 24 hour period.
Timepoint [1] 0 0
24 hours after surgery
Secondary outcome [1] 0 0
Immediate post-operative hypertension (first 2 hours)
Timepoint [1] 0 0
24 hours after surgery
Secondary outcome [2] 0 0
Pain scores at zero (time of extubation), 1, 2, 4, 12, 24 hours post operatively
Timepoint [2] 0 0
24 hours after surgery
Secondary outcome [3] 0 0
Analgesic efficacy at 24 hours
Timepoint [3] 0 0
24 hours after surgery
Secondary outcome [4] 0 0
Incidence of post-operative nausea and vomiting (first 24 hours)
Timepoint [4] 0 0
24 hours after surgery
Secondary outcome [5] 0 0
Sedation or respiratory depression (first 24 hours)
Timepoint [5] 0 0
24 hours after surgery
Secondary outcome [6] 0 0
Safety Monitoring (Serious adverse side effects)
Timepoint [6] 0 0
24 hours after surgery
Secondary outcome [7] 0 0
Post-operative AMI
Timepoint [7] 0 0
24 hours after surgery
Secondary outcome [8] 0 0
Post-operative renal failure
Timepoint [8] 0 0
24 hours after surgery
Secondary outcome [9] 0 0
Post-operative thromboembolic stroke
Timepoint [9] 0 0
24 hours after surgery
Secondary outcome [10] 0 0
Post-operative intracranial haemorrhage
Timepoint [10] 0 0
24 hours after surgery

Eligibility
Key inclusion criteria
- Supratentorial craniotomy, glasgow coma scale 15
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3050 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Melbourne Health
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT00455117
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Daryl L Williams, MBBS
Address 0 0
Director of Anaesthesia, Royal Melbourne Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications