Actively Recruiting
Intranasal Versus Intravenous Fentanyl for Procedural Analgesia in Preterm Neonates A Randomized Controlled Trial
Led by Ain Shams University · Updated on 2025-10-01
75
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Preterm neonates often experience significant pain during medical procedures, and managing this pain effectively is critical to avoid long-term developmental issues. Researchers are evaluating intranasal fentanyl compared to intravenous fentanyl for pain relief during procedures in preterm neonates. This randomized controlled trial aims to determine which method provides better procedural analgesia using a pain scoring system. Participants will be randomly assigned to one of three groups: intravenous fentanyl, intranasal fentanyl delivered directly into the nostrils, or intranasal fentanyl administered with a nasal atomizer. The intranasal fentanyl dose is 1.5 mcg/kg per administration, with a possible second dose after 5 minutes if needed, while the intravenous fentanyl dose is 1 mcg/kg as standard care. Pain scores will be assessed before and after fentanyl administration during medical procedures. During the study, newborns will undergo thorough clinical examination and history review to confirm eligibility. Researchers will monitor pain using the Premature Infant Pain Profile (PIPP) scale before and within 5 minutes after fentanyl use. Vital signs such as heart rate, respiratory rate, oxygen saturation, blood pressure, and oxygen levels will be recorded at baseline and at intervals up to 60 minutes post-treatment. Adverse events, including apnea, bradycardia, desaturation, and nasal irritation, will be closely observed. Participation lasts through the procedural pain period and monitoring for one hour afterward.
CONDITIONS
Brief Title
Intranasal Versus Intravenous Fentanyl For Procedural Analgesia in Preterm Neonates
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Known contraindications for fentanyl use, including fentanyl hypersensitivity and liver failure
- Known contraindications for intranasal drug administration such as choanal atresia, nasal mucosal erosion, and epistaxis
- Post-surgical patients
- Patients sedated by fentanyl infusion or midazolam infusion
- Evidence of neurological disease with disturbed consciousness, such as intraventricular hemorrhage grade III or IV, hypoxic ischemic encephalopathy, or inborn error of metabolism
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedural administration with monitoring for 1 hour following fentanyl use
Participants receive fentanyl via intravenous or intranasal routes during painful procedures to manage procedural pain.
1 procedure visit with monitoring for 1 hour post-treatment
Trial Site Locations
Total: 1 location
1
Ain Shams University
Cairo, Egypt
Actively Recruiting
Research Team
P
Passant Osama Fahmy, M.Sc
R
Rabab Gameel Allam, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
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