The purpose of this study is to assess the efficacy and safety of intravenous fentanyl on reducing the pain of lumbar puncture in neonates. This study will be conducted on 46 neonates admitted to NICU of Shahid Sadoughi hospital for whom lumbar puncture is performed for the first time.Infants with neuromuscular disorders and those with consumption of sedatives or hypnotics during 12 hours before the study,will be excluded from the study.
The neonates will be randomly allocated in two groups .In one group 2mcg/kg of intravenous fentanyl diluted to 0.2 ml with N/S will be injected intravenously. In the second group 0.2ml N/S will be administered as placebo. In both groups, fentanyl or placebo will be injected 5 min befor lumbar puncture. O2 saturation and PR will be recoreded before and during injection of fentanyl every 2 min until 10 min. Pain score and side effects will be evaluated and compared between two groups when needle inserts the skin for lumbar puncture.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014022616761N1
Registration date:2014-04-16, 1393/01/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-04-16, 1393/01/27
Registrant information
Name
Samane Habibian
Name of organization / entity
Shahid Sadoughi Univercity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 2425 1798
Email address
dr.habibian1@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi Univercity of Medical Sciences,Yazd
Expected recruitment start date
2013-07-23, 1392/05/01
Expected recruitment end date
2014-02-20, 1392/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Venous Fentanyl on Reducing the Pain of Lumbar Puncture in Neonates
Public title
Effect of Fentanyl on Pain Reduction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Gestational age > 34 weeks ; neonates hospitalized in NICU; Weight >1800gr; neonates who need lumbar puncture according to clinical judgment
Exclusion criteria: age >2 months; neuromuscular disorders; use of sedative or hypnotic drugs 12 hours before LP; low level of consciousness
Age
From 1 day old to 2 months old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Sadoughi Univercity of Medical Sciences
Street address
Bahonar Square
City
Yazd
Postal code
۸۹۱۵۸۴۵۳۵۴
Approval date
2014-03-08, 1392/12/17
Ethics committee reference number
۱۷/۱/۲۵۷۴۲۸/پ
Health conditions studied
1
Description of health condition studied
Diseases of centeral nervous system
ICD-10 code
G99
ICD-10 code description
Other disorders of nervous system in diseases classified elsewhere
Primary outcomes
1
Description
Pain reduction and obtaining pain score of 3 and less
Timepoint
When needle inserts the skin
Method of measurement
observation
2
Description
Succeful lumbar puncture
Timepoint
When lumbar puncture to complete
Method of measurement
Observe
Secondary outcomes
1
Description
Side effects
Timepoint
30 min after drug usage
Method of measurement
Clinical exam and monitoring
Intervention groups
1
Description
Intervention group: Single dose of intravenous fentanyl; manufactured by Caspiantamin pharmaceutical Co. Iran; 2 mcg/kg diluted to 0.2 ml with normal saline
Category
Treatment - Other
2
Description
control group:single dose of normal saline 0.2ml;manufactured by Samen pharmaceutical Co. Iran.