In this open labeled, parallel-group clinical trial, we compared success rate of lumbar puncture in lateral decubitus and sitting position.
Participants/Inclusion and exclusion criteria
1 to 5-year-old children who need lumbar puncture
Intervention groups
In group I, lumbar puncture was performed in lateral decubitus position, and in group II, lumbar puncture was performed in sitting position.
Main outcome variables
Rate of successful lumbar puncture; baseline anxiety and pain scores during lumbar puncture
General information
Reason for update
Acronym
-
IRCT registration information
IRCT registration number:IRCT20091027002639N22
Registration date:2020-03-16, 1398/12/26
Registration timing:retrospective
Last update:2020-03-16, 1398/12/26
Update count:0
Registration date
2020-03-16, 1398/12/26
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
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2019-09-22, 1398/06/31
Actual recruitment start date
2019-05-22, 1398/03/01
Actual recruitment end date
2019-09-22, 1398/06/31
Trial completion date
2019-09-22, 1398/06/31
Scientific title
Effect of sitting and lateral decubitus position in lumbar puncture of children
Public title
Comparison of success rates of performing lumbar puncture in 1-5 year-old children in lateral decubitus versus sitting position
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Children aged 1-5 years
ٌWith the American Society of Anesthesiologists (ASA) physical status I-II
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;
Age
From 1 year old to 5 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Actual sample size reached:
80
More than 1 sample in each individual
Actual sample size in each individual:
1
1
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization by random numbers
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
Province
Yazd
Postal code
8915887857
Approval date
2019-05-19, 1398/02/29
Ethics committee reference number
IR.SSU.MEDICINE.REC.1398.067
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
Rate of successful lumbar puncture
Timepoint
During needle insertion to skin for lumbar puncture
Method of measurement
When the free flow of cerebrospinal fluid was observed upon the first attempt
2
Description
Anxiety score during needle insertion to skin
Timepoint
Before skin needle insertion for lumbar puncture
Method of measurement
Questionnaire
3
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
Intervention group 1: 0.5 mg/kg midazolam ampule of 5 mg/milliliter from Aburaihan Co. Tehran, Iran will be injected five minutes before lumbar puncture and lumbar puncture of child will be done in sitting position
Category
Other
2
Description
Intervention group 2: 0.5 mg/kg midazolam ampule of 5 mg/milliliter from Aburaihan Co. Tehran, Iran will be injected five minutes before lumbar puncture and lumbar puncture of child will be done in lateral decubitus position