Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/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
Sex
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
1/09/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2008
Sample size
Target
Accrual to date
Final
130
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/ct2/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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00455117