Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000065695
Ethics application status
Approved
Date submitted
28/07/2005
Date registered
1/08/2005
Date last updated
1/08/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of intrathecal pethidine on shivering in women having caesarean sections: a prospective randomised controlled trial
Scientific title
The effect of intrathecal pethidine on shivering in women having caesarean sections: a prospective randomised controlled trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shivering in women having caesarean sections under spinal anaesthetics 137 0
Condition category
Condition code
Anaesthesiology 156 156 0 0
Anaesthetics
Reproductive Health and Childbirth 157 157 0 0
Normal pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Women presenting for emergency caesarean section (E1-E3) will be randomised to one of two groups, and either receive intrathecal pethidine 10mg with bupivacaine, or intrathecal fentanyl 10mcg with bupivacaine. Our hypothesis is that women receiving pethidine will experience less shivering than those receiveing fentanyl.
The intervention will last four hours only.
Intervention code [1] 75 0
None
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 192 0
Shivering
Timepoint [1] 192 0
It will be measured on arrival to the operating theatre, at 20 minutely intervals during the operation, and once in recovery.
Secondary outcome [1] 445 0
Height of block
Timepoint [1] 445 0
Will be recorded during the operation.
Secondary outcome [2] 446 0
Presence or absence of nausea, vomiting, itch, intraoperative pain, hypotension.
Timepoint [2] 446 0
Will be recorded during the operation.
Secondary outcome [3] 447 0
VAS pain scores
Timepoint [3] 447 0
at 4 hours
Secondary outcome [4] 448 0
Time to first supplemental analgesia requirement.
Timepoint [4] 448 0
Will be recorded during the operation.

Eligibility
Key inclusion criteria
Women having urgent caesarean sections (E1-E3).
Minimum age
Not stated
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Epidural catheter in situ. Spinal anaesthetic not the most appropriate anaesthetic. ASA > 3- code greens.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The syringe containing the opiate will be prepared by the hospital pharmacy. The syringes for both groups will appear identical. The syringes will be numbered 0-40 by pharmacy. Pharmacy will randomly number the syringes (computer generated). The anaesthetic nurse will randomly choose a syringe from a box containing the syringes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated. No restriction.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 210 0
Self funded/Unfunded
Name [1] 210 0
Country [1] 210 0
Primary sponsor type
Hospital
Name
Box Hill Hospital, Eastern Health
Address
Country
Australia
Secondary sponsor category [1] 157 0
None
Name [1] 157 0
none required
Address [1] 157 0
Country [1] 157 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36308 0
Address 36308 0
Country 36308 0
Phone 36308 0
Fax 36308 0
Email 36308 0
Contact person for public queries
Name 9264 0
Dr Gabe Snyder
Address 9264 0
Box Hill Hospital
Nelson Road
Box Hill VIC 3128
Country 9264 0
Australia
Phone 9264 0
+61 3 9895333
Fax 9264 0
Email 9264 0
gabrielsnyder@hotmail.com
Contact person for scientific queries
Name 192 0
Dr Gabe Snyder
Address 192 0
Box Hill Hospital
Nelson Road
Box Hill VIC 3128
Country 192 0
Australia
Phone 192 0
+61 3 9895333
Fax 192 0
Email 192 0
gabrielsnyder@hotmail.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.