A Phase 4 interventional study of Fentanyl in Pain, sponsored by HaEmek Medical Center, Israel. Completed at 1 site in Israel. Open to participants aged Up to 3 Months. Per ClinicalTrials.gov, last updated 2018-02-06.
Sponsored by HaEmek Medical Center, Israel · Phase 4, Interventional, and Treatment
Neonatal intensive care unit patients undergoes many painful procedures during their hospitalization. Effective pain control in such procedures as intubation, catheterization, central line insertion, chest tube insertion, etc. is an important part of treatment. Opioids administration is a common practice for acute pain prevention. Fentanyl is the preferred opioid due to it rapid onset and short duration of action.
Fentanyl may be given intravenously, transcutaneous transmucosal and intranasal. Intranasal administration is practiced for about 20 years. A rich vascular supply in a nose provides rapid absorption of the drug. This uninvasive root is now popular for pain prevention and treatment. There are about 20 trials with intranasal fentanyl administration to children from 6 month old to 18 years. The investigators did not find information about this way of administration in neonates.
In our pilot study the investigators want to check if intranasal administration of fentanyl is safe and effective in pain prevention in term and preterm neonates during invasive procedures and to compare it with intravenous route of administration.
HaEmek Medical Center, Israel is the lead sponsor of 228 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Term and preterm neonates that require invasive procedures (elective or semielective intubation, central line insertion , chest drain or abdominal drain)
Exclusion Criteria:
Intranasal Fentanyl 1.5-2 mcg/kg
Drug: Fentanyl
Intravenous Fentanyl 1-1.5 mcg/kg
Drug: Fentanyl
A neonate will recieve Fentanyl intranasal or intravenous 5 minutes before the procedure The nurse will check his pain scale If the pain scale will be more than 4 the neonate will recieve the second dose of Fentanyl
Also known as: Beatryl
Pain scale - N-PASS
Time frame: before the intervention and till one our after intervention
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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HaEmek Medical Center, Israel