Intranasal Versus Intravenous Fentanyl For Procedural Analgesia in Preterm Neonates

NCT ID: NCT07190625

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-24
• Study Completion Date: 2026-06-01

Brief Summary

Pain in neonatal life has profound long-term developmental impacts, so pain control is crucial. The intranasal (IN) route is a minimally invasive method for rapidly delivering fentanyl to provide short-term analgesia and sedation in adults and pediatrics, but few data exist about its use in neonates. Meanwhile, intravenous fentanyl is widely used in sedation and pain management.

Using intranasal fentanyl as an analgesic in preterm neonates may provide a rapid, effective, noninvasive route for administration.

Detailed Description

The aim of this study is to evaluate the effect of intranasal fentanyl versus the intravenous route for procedural pain management in preterm neonates as assessed by pain scoring system before and after the procedure.

Enrolled neonates will be allocated randomly to one of the three groups during painful procedure, using single blinded method, as scoring will occur by a different physician than the researcher.

Atomizer group: will receive intranasal fentanyl (@fentanyl hamein 50 mcg/1 ml, manufactured by Sunny Pharmaceutical) using a nasal atomizer; the dose of INF is 1.5 µg/kg/dose.

Direct nasal group: will receive intranasal fentanyl directly installed into the nostrils with the same dose.

Typically, one dose is given during the procedure; after 5 minutes, a second dose could be administered based on the clinical assessment (maximum two doses per procedure), with reassessment of the pain score.

o Intravenous group: will receive intravenous fentanyl with a dose of 1 μg/kg as the standard of care.

All of the following data will be obtained:

Full history taking: antenatal, natal, and postnatal history Gestational age will be estimated using the date of the last menstrual period and confirmed by the new Ballard scoring system.

Full clinical examination: including general, cardiopulmonary, abdominal, and neurological examinations and anthropometric measurements.

Type of procedure done to the patient, number of attempts if more than once, and number of intranasal fentanyl doses needed.

Type of respiratory support at the time of intranasal fentanyl administration.

Effectiveness of intranasal fentanyl will be assessed using:

Premature Infant Pain Profile (PIPP) scale The pre-procedure PIPP scale will be recorded just before administration of the first dose of IN fentanyl and commencement of the painful procedure, while the post-procedure PIPP score will be recorded within 5 minutes of fentanyl administration.

PIPP scores range from 0 to 21. A PIPP score of 0-6 suggests minimal or no pain, 7-12 indicates moderate pain, and a score ≥ 13 is interpreted as severe pain.

Physiological parameters of heart rate, respiratory rate, oxygen saturation, blood pressure, and fraction of inspired oxygen (FiO2) at baseline (just before fentanyl administration) and at pre-specified intervals (15, 30, 45, and 60 min) after fentanyl use.

Monitor adverse events after fentanyl use, such as apnea (cessation of breathing for >20 s), bradycardia (heart rate < 100 beats/minute), desaturation (oxygen saturation < 80%) , and chest wall rigidity associated with laryngospasm for 60 min after IN fentanyl administration. Local effects include nasal discomfort and irritation.

Conditions

Procedural Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

intravenous group

this group of neonates will recieve intravenous fentanyl during procedure

Group Type: ACTIVE_COMPARATOR

fentanyl intravenous

Intervention Type: DRUG

giving intravenous fentanyl

direct intranasal group

this group of neonates will recieve direct intranasal fentanyl during procedure

Group Type: ACTIVE_COMPARATOR

fentanyl intranasal direct

Intervention Type: DRUG

giving intranasal fentanyl directly into nostrils

nasal atomizer group

this group of neonates will recieve intranasal fentanyl with atomizer during procedure

Group Type: ACTIVE_COMPARATOR

Fentanyl intranasal using atomizer

Intervention Type: DRUG

giving intranasal fentanyl using nasal atomizer

Interventions

fentanyl intravenous

giving intravenous fentanyl

Intervention Type: DRUG

Fentanyl intranasal using atomizer

giving intranasal fentanyl using nasal atomizer

Intervention Type: DRUG

fentanyl intranasal direct

giving intranasal fentanyl directly into nostrils

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Preterm neonates with gestational age between 28 and 36 weeks gestation.
• Undergoing painful procedures such as central venous access insertion, elective endotracheal intubation, and lumbar puncture.

Exclusion Criteria

• known contraindications for fentanyl use, such as fentanyl hypersensitivity and liver failure.
• Known contraindication for intranasal administration of drugs (choanal atresia, nasal mucosal erosion, and epistaxis)
• Post-surgical patients.
• Patients sedated by fentanyl infusion / midazolam infusion.
• Evidence of neurological disease with disturbed conscious level, such as intraventricular hemorrhage grade III or IV, hypoxic ischemic encephalopathy, or inborn error of metabolism.

• Maximum Eligible Age: 28 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Passant Fahmy, M.Sc

Role: PRINCIPAL_INVESTIGATOR

Assisstant lecturer

Locations

Ain Shams University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Passant Osama Fahmy, M.Sc

Role: CONTACT

Passant.Osama@med.asu.edu.eg

01066724641

Rabab Gameel Allam, MD

Role: CONTACT

Other Identifiers

FMASU MD342/2023

Identifier Type: -

Identifier Source: org_study_id