An Early Phase 1 interventional study of fentanyl intravenous and Fentanyl intranasal using atomizer in Procedural Pain, sponsored by Ain Shams University. Recruiting at 1 site in Egypt. Open to participants aged Up to 28 Days. Per ClinicalTrials.gov, last updated 2025-10-01.
Sponsored by Ain Shams University · Early Phase 1, Interventional, and Supportive care
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.
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.
241 studies on the registry are indexed under Pain, Procedural; 64 are open to participants now.
This study's planned enrollment of 75 is below the median of 90 across 227 interventional studies indexed under Pain, Procedural.
Browse Pain, Procedural studies →Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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this group of neonates will recieve intravenous fentanyl during procedure
Drug: fentanyl intravenous
this group of neonates will recieve direct intranasal fentanyl during procedure
Drug: fentanyl intranasal direct
this group of neonates will recieve intranasal fentanyl with atomizer during procedure
Drug: Fentanyl intranasal using atomizer
giving intravenous fentanyl
giving intranasal fentanyl using nasal atomizer
giving intranasal fentanyl directly into nostrils
procedural pain managment
The efficacy of different modalities of intranasal fentanyl, either nasal atomizer or direct method, versus intravenous administration in neonatal pain management using Premature Infant Pain Profile (PIPP) scale before and after the administration. PIPP score ranges 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.
Time frame: from giving the fentanyl before the procedure till one hour after .
Plan to share: Undecided
No publications or documents are linked to this record.
Started Dec 2023 (actual). Primary completion is estimated for Mar 2026, 26 months after the start.
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Studies of the drug tested here: Fentanyl