This study will be done to answer this question that whether or not intravenous midazolam with maternal presence is more efficient than intravenous midazolam alone in reduction of pain and anxiety of lumbar puncture (LP) in 6-24 month old children. In a single blind clinical trial, sixty 6-24 month old children, who are to be admitted to Pediatric Ward of Shahid Sadoughi Hospital, Yazd, Iran and doing of LP is necessary based on clinical judgment of pediatricians, will be distributed randomly into two groups. In both groups, 0.5 mg/kg midazolam intravenously will be injected five minutes before LP. In group I, lumbar puncture will be done with maternal presence and in group II, mother is out of the room. Primary outcomes include anxiety score before skin needle insertion and pain score during needle insertion to skin for LP. Secondary outcomes include success rate in reducing of anxiety during skin needle insertion (anxiety score of four and more three) and success rate in reducing of pain when the needle will be inserted to skin for LP (pain score of less than three). The trial uses computer generated equal simple randomization by random numbers and data collectors, outcome assessors and data analysts are kept blinded to the allocation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201609222639N19
Registration date:2016-10-01, 1395/07/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-10-01, 1395/07/10
Registrant information
Name
Razieh Fallah
Name of organization / entity
Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Country
Iran (Islamic Republic of)
Phone
+98 35 3822 4000
Email address
fallah@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2015-07-22, 1394/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of midazolam alone and midazolam with maternal presence in lumbar puncture of 6-24 month old children
Public title
Clinical trial of efficacy evaluation of midazolam alone and midazolam with maternal presence on reduction of pain and anxiety of lumbar puncture of 6-24 month old children
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: Age range of 6-24 months; undergone lumbar puncture based on clinical judgment of the pediatrician; not received sedative hypnotic drugs within the past 48 hours
Exclusion criteria: Neurodevelopmental delay or mental retardation; loss of consciousness (Glasgow coma scale less than 12); symptoms of increased intracranial pressure; done lumbar puncture more than two times; previously undergone lumbar puncture
Age
From 6 months old to 2 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Yazd Medical Sciences University,Yazd, Iran
Street address
Central building of university, Bahonar square
City
Yazd
Postal code
Approval date
2015-03-17, 1393/12/26
Ethics committee reference number
IR.SSU.MEDICINE.REC.13930128
Health conditions studied
1
Description of health condition studied
Other disorders of central nervous system
ICD-10 code
G90-G99
ICD-10 code description
Other disorders of central nervous system
Primary outcomes
1
Description
Anxiety score before skin needle insertion for lumbar puncture
Timepoint
Before skin needle insertion for lumbar puncture
Method of measurement
Questionnaire
2
Description
Pain score during needle insertion to skin
Timepoint
During needle insertion to skin for lumbar puncture
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Success rate in reducing of anxiety during skin needle insertion (anxiety score of four and more three)
Timepoint
During needle insertion to skin for lumbar puncture
Method of measurement
Questionnaire
2
Description
Success rate in reducing of pain (pain score of less than three)
Timepoint
During needle insertion to skin for lumbar puncture
Method of measurement
Questionnaire
Intervention groups
1
Description
0.5 mg/kg midazolam ampule of 5 mg/milliliter from Aburaihan Co. Tehran, Iran will be injected five minutes before lumbar puncture and mother will be out of the room during lumbar puncture of her child
Category
Other
2
Description
0.5 mg/kg midazolam ampule of 5 mg/milliliter from Aburaihan Co. Tehran, Iran will be injected five minutes before lumbar puncture and during lumbar puncture of the child, mother will be in the room and sit face to face of her child and catch child hand in her hand and dandle it while the mother and she is face to face of the person performing the lumbar puncture