Diseases of centeral nervous system. Other disorders of nervous system in diseases classified elsewhere
Conditions
Interventions
Intervention 1: Intervention group: Single dose of intravenous fentanyl
manufactured by Caspiantamin pharmaceutical Co. Iran
2 mcg/kg diluted to 0.2 ml with normal saline. Intervention 2: control group:single dose of normal saline 0.2ml
manufactured by Samen pharmaceutical Co. Iran.
Treatment - Other
Placebo
Intervention group: Single dose of intravenous fentanyl
2 mcg/kg diluted to 0.2 ml with normal saline
control group:single dose of normal saline 0.2ml
Sponsors
Deputy of research-Shahid Sadoughi University of Medical Sciences
Eligibility
Sex/Gender
All
Age
1 Days to 2 Months
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain reduction and obtaining pain score of 3 and less. Timepoint: When needle inserts the skin. Method of measurement: observation.;Succeful lumbar puncture. Timepoint: When lumbar puncture to complete. Method of measurement: Observe. | — |
Secondary
| Measure | Time frame |
|---|---|
| Side effects. Timepoint: 30 min after drug usage. Method of measurement: Clinical exam and monitoring. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr.Samane Habibian
Shahid Sadoughi University of Medical Sciences
Outcome results
None listed