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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02125201
• Other study ID #: EMC-0089-13 - CTIL
• Status: Completed
• Phase: Phase 4
• First received: March 21, 2014
• Last updated: February 5, 2018
• Start date: June 2014
• Est. completion date: March 2015

Study information

• Verified date: February 2018
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Months

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

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

Locations

Country	Name	City	State
Israel	NICU	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain scale - N-PASS		before the intervention and till one our after intervention