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

NCT02125201 | Completed Phase 4

• 1 other identifier: EMC-0089-13 - CTIL
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

intranasal fentanyl; newborn

Outcome Measures

Primary Outcomes (1)

• Pain scale - N-PASS

  before the intervention and till one our after intervention

Study Arms (2)

intranasal fentanyl

EXPERIMENTAL

Intranasal Fentanyl 1.5-2 mcg/kg

Drug: Fentanyl

intravenous fentanyl

ACTIVE COMPARATOR

Intravenous Fentanyl 1-1.5 mcg/kg

Drug: Fentanyl

Interventions

Fentanyl DRUG

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

intranasal fentanyl; intravenous fentanyl

Eligibility Criteria

• Age: Up to 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Study Sites (1)

NICU

Afula, Israel

Location

MeSH Terms

Conditions

Pain

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Marina Peniakov, MD

  HaEmek Medical Center, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: March 21, 2014
• First Posted: April 29, 2014
• Study Start: June 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: February 6, 2018

Record last verified: 2018-02

Locations

IL (1)