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

Phase 4

Completed

• Conditions: Pain
• Interventions: Drug: Fentanyl

• Registration Number: NCT02125201
• Lead Sponsor: HaEmek Medical Center, Israel

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-21
• Study First Submitted QC: 2014-04-28
• Study First Posted: 2014-04-29
• Study Start: 2014-06
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-05
• Last Update Posted: 2018-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

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

Exclusion Criteria

1. Neonates with prolonged analgesic treatment before the procedure
2. Neonates with neurologic problem which can interact with pain assessment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intranasal fentanyl	Fentanyl	Intranasal Fentanyl 1.5-2 mcg/kg
intravenous fentanyl	Fentanyl	Intravenous Fentanyl 1-1.5 mcg/kg

Primary Outcome Measures

Name	Time	Method
Pain scale - N-PASS	before the intervention and till one our after intervention

Trial Locations

Locations (1)

NICU; 🇮🇱 Afula, Israel