Lumbar puncture is one of the most important diagnostic and therapeutic procedures in children which needs immobilization of the child. The purpose of this study is to compare efficacy and safety of melatonin and gabapentin in reduction of pain and anxiety of lumbar puncture in children. In the study , 90 children whom are admitted to Pediatric Ward of Shahid Sadoughi hospital and lumbar puncture is done in them for the first time , are evaluated .
The children are distributed into three groups. In one group , 15 mg/kg of gabapentin is diluted with normal saline , in other one 0.3mg/kg of melatonin is diluted with normal saline and in third group , 5 milliliter normal saline as placebo will be given . In all groups, oral drug or placebo will be prescribed one hour before lumbar puncture . Anxiety score in every 15 minutes and during lumbar puncture , pain score when needle inserts to skin for lumbar puncture and side effects of drugs are to be compared .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112032639N7
Registration date:2011-12-11, 1390/09/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-12-11, 1390/09/20
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
Research Deputy, Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Expected recruitment start date
2011-09-23, 1390/07/01
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy of melatonin and gabapentin in reducing of pain and anxiety of lumbar puncture in children
Public title
Melatonin and gabapentin in pain of lumbar puncture in children
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: children aged one month -7 years; Without systemic diseases and ASA class I or II ; Lumbar puncture are done for the first time; No usage of sedative or hypnotic drugs in recent 48 hours
Exclusion Criteria: History of drug allergy; Having neurodevelopmental delay or mental retardation; Loss of consciousness and GCS less than 12
Age
To 7 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Street address
Bahonar square
City
Yazd
Postal code
Approval date
2011-10-06, 1390/07/14
Ethics committee reference number
39321/1/17/پ
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
succeful lumbar puncture without anxiety and pain
Timepoint
one hour after drug useage during lumbar puncture
Method of measurement
clinical exam
2
Description
obtain of pain score less than 4 in reduction of pain
Timepoint
one hour after drug useage during lumbar puncture
Method of measurement
clinical exam
3
Description
obtain of anxiety score 4 and more in reduction of anxiety of lumbar puncture in children.
Timepoint
one hour after drug useage during lumbar puncture
Method of measurement
clinical exam
Secondary outcomes
1
Description
side effects
Timepoint
one hour after drug usage
Method of measurement
clinical exam
2
Description
mean of time to obtain antianxiety situation
Timepoint
every 15 minutes
Method of measurement
clinical exam
3
Description
mean of time to obtain painless situation
Timepoint
one hour after drug usage during lumbar puncture
Method of measurement
clinical exam
Intervention groups
1
Description
single dose of oral 15 mg/kg of gabapentin is diluted with normal saline
Category
Treatment - Other
2
Description
single dose of oral 0.3mg/kg of melatonin is diluted with normal saline
Category
Treatment - Other
3
Description
5 milliliterof oral normal saline
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi hospital - Pediatric ward
Full name of responsible person
Dr.Razieh Fallah
Street address
Shahid Sadoughi Hospital, Sina Blvd, Shahid Ghandi Blvd
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of research -Shaheed Sadoughi University of Medical Sciences ,Yazd,Iran
Full name of responsible person
Dr. Fatemah Ezodinee
Street address
Bahonar Square ,University central byilding
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of research -Shaheed Sadoughi University of Medical Sciences ,Yazd,Iran
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences, Yazd,Iran
Full name of responsible person
Dr.razieh Fallah
Position
assisstant professor
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital, Sina Blvd, Shahid Ghandi Blvd
City
Yazd
Postal code
Phone
+98 35 1822 4000
Fax
Email
FALLAH@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)