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Trial registered on ANZCTR


Registration number
ACTRN12611001059954
Ethics application status
Approved
Date submitted
10/10/2011
Date registered
11/10/2011
Date last updated
11/10/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Granisetron and incidence of shivering in children after spinal anesthesia
Scientific title
Premedication with Granisetron prevents shivering during spinal anaesthesia in children
Secondary ID [1] 273181 0
'Nil'
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
shivering during spinal anesthesia in children 278931 0
Condition category
Condition code
Anaesthesiology 279112 279112 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Effect of Premedication with Granisetron on incidence of shivering during spinal anesthesia in children
intravenous 10 mcg/Kg granisetron diluted in 10 ml saline 0.9% to be given over 5 minutes just before spinal puncture.
Spinal block was done by intrathecal hyperbaric bupivacine 0.5% (0.5 mg/Kg).
Intervention code [1] 269511 0
Prevention
Intervention code [2] 269515 0
Treatment: Drugs
Comparator / control treatment
Intravenous 10 ml 0.9% saline to be given over 5 minutes just before spinal puncture.
Control group
Placebo

Outcomes
Primary outcome [1] 279755 0
Incidence of shivering
Shivering was assessed using scale of Tsai and Chu.
0 no shivering
1 Mild fasciculations of face or neck
2 Visible tremor involving more than one muscle group
3 Gross muscular activity involving the entire body
Timepoint [1] 279755 0
shivering were recorded before spinal anesthesia, 15, 30, 60& 90 min. after spinal anesthesia.
Secondary outcome [1] 294381 0
Motor block was assessed using the Bromage scale recording the ability to flex hip, knee and ankle.
Timepoint [1] 294381 0
10 minute after injection of bupivacaine
Secondary outcome [2] 294382 0
Sensory block was assessed by bilateral pin prick at each dermatome to elicit grimace or acknowledgement of pain.
Timepoint [2] 294382 0
10 minute after injection of bupivacaine

Eligibility
Key inclusion criteria
80 children ASA 1 and 2 scheduled for lower limb surgery under spinal anaesthesia were entered into study
Minimum age
2 Years
Maximum age
5 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria included: refusal of parents, coagulopathy, spinal congenital anomalies, neurological abnormality, allergy to local anesthetics and surgery scheduled to last for more than 90 minutes, children with hypo or hyperthyroidism, children with hypothermia or hyperthermia and those who needed intraoperative blood transfusion.

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)
Randomization was performed using a computer based random number generator in permutated blocks of varying sizes and the assignment entered in sealed envelopes that were not opened till informed consent was obtained. The drug was mixed and administered by a nurse who took no further part in the study. The patient, parent, anesthesiologist, observer gathering data and nurses taking care of the patient in the preoperative period remained blinded to the group assignment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization was performed using a computer based random number generator in permutated blocks of varying sizes and the assignment entered in sealed envelopes that were not opened till informed consent was obtained.
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
Completed
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 outside Australia
Country [1] 3905 0
Egypt
State/province [1] 3905 0

Funding & Sponsors
Funding source category [1] 270004 0
Self funded/Unfunded
Name [1] 270004 0
Address [1] 270004 0
Country [1] 270004 0
Primary sponsor type
Individual
Name
Yasser M. Amr
Address
Anesthesia department- Tanta university hospitals- Tanta university
El- Geish street
Postal Code: 31257
Tanta- Egypt
Country
Egypt
Secondary sponsor category [1] 268984 0
Individual
Name [1] 268984 0
Ahmed A. Eldaba
Address [1] 268984 0
Anesthesia department- Tanta university hospitals- Tanta university
El- Geish street
Postal Code: 31257
Tanta- Egypt
Country [1] 268984 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271965 0
Faculty of medicine- Tanta university
Ethics committee address [1] 271965 0
Anesthesia department- Tanta university hospitals- Tanta university
El- Geish street
Postal Code: 31257
Tanta- Egypt
Ethics committee country [1] 271965 0
Egypt
Date submitted for ethics approval [1] 271965 0
02/02/2011
Approval date [1] 271965 0
02/03/2011
Ethics approval number [1] 271965 0

Summary
Brief summary
80 children aged from 2-5 years scheduled for surgery in lower limb were prepared for spinal anesthesia. Children were classified into two groups, Group 1 (40 children) received intravenous 10 mcg/Kg granisetron diluted in 10 ml saline 0.9% and Group 2 (40 children) received intravenous 10 ml 0.9% saline to be given over 5 minutes just before spinal puncture. Shivering, core temperature levels of motor and sensory block were assessed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33251 0
Address 33251 0
Country 33251 0
Phone 33251 0
Fax 33251 0
Email 33251 0
Contact person for public queries
Name 16498 0
Yasser M. Amr
Address 16498 0
Anesthesia department- Tanta university hospitals- Tanta university
El- Geish street
Postal Code: 31257
Tanta- Egypt
Country 16498 0
Egypt
Phone 16498 0
201224462887
Fax 16498 0
Email 16498 0
yasser.amr@gmail.com
Contact person for scientific queries
Name 7426 0
Yasser M. Amr
Address 7426 0
Anesthesia department- Tanta university hospitals- Tanta university
El- Geish street
Postal Code: 31257
Tanta- Egypt
Country 7426 0
Egypt
Phone 7426 0
201224462887
Fax 7426 0
Email 7426 0
yasser.amr@gmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary