NCT07190625

Intranasal Versus Intravenous Fentanyl For Procedural Analgesia in Preterm Neonates

Intranasal Versus Intravenous Fentanyl For Procedural Analgesia in Preterm Neonates : A Randomized Controlled Trial

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 28 Days
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	fentanyl intravenous	giving intravenous fentanyl
DRUG	Fentanyl intranasal using atomizer	giving intranasal fentanyl using nasal atomizer
DRUG	fentanyl intranasal direct	giving intranasal fentanyl directly into nostrils

Timeline

• Start date: 2023-12-24
• Primary completion: 2026-03-01
• Completion: 2026-06-01
• First posted: 2025-09-24
• Last updated: 2025-10-01

Locations

1 site across 1 country: Egypt