Skip to main content
Clinical Trials/NCT02125201
NCT02125201
Completed
Phase 4

Effectiveness of Intranasal Versus Intravenous Fentanyl in Preterm and Term Newborns for Pain Prevention

HaEmek Medical Center, Israel1 site in 1 country21 target enrollmentJune 2014
ConditionsPain
InterventionsFentanyl

Overview

Phase
Phase 4
Intervention
Fentanyl
Conditions
Pain
Sponsor
HaEmek Medical Center, Israel
Enrollment
21
Locations
1
Primary Endpoint
Pain scale - N-PASS
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
June 2014
End Date
March 2015
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Peniakov Marina

Doctor

HaEmek Medical Center, Israel

Eligibility Criteria

Inclusion Criteria

  • Term and preterm neonates that require invasive procedures (elective or semielective intubation, central line insertion , chest drain or abdominal drain)

Exclusion Criteria

  • Neonates with prolonged analgesic treatment before the procedure
  • Neonates with neurologic problem which can interact with pain assessment

Arms & Interventions

intravenous fentanyl

Intravenous Fentanyl 1-1.5 mcg/kg

Intervention: Fentanyl

intranasal fentanyl

Intranasal Fentanyl 1.5-2 mcg/kg

Intervention: Fentanyl

Outcomes

Primary Outcomes

Pain scale - N-PASS

Time Frame: before the intervention and till one our after intervention

Study Sites (1)

Loading locations...

Similar Trials