Intranasal Versus Intravenous Fentanyl For Procedural Analgesia in Preterm Neonates
ConditionProcedural Pain
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
AgeUp to 28
SponsorAin Shams University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
fentanyl intravenous
Druggiving intravenous fentanyl
Fentanyl intranasal using atomizer
Druggiving intranasal fentanyl using nasal atomizer
fentanyl intranasal direct
Druggiving intranasal fentanyl directly into nostrils
Treatment groups
75 Participants
are divided into 3 treatment groupsGroup A: intravenous groupActive comparator 1 intervention
Group B: direct intranasal groupActive comparator 1 intervention
Group C: nasal atomizer groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 .Sponsors and contacts
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Source ClinicalTrials.gov