Intranasal Versus Intravenous Fentanyl For Procedural Analgesia in Preterm Neonates
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: fentanyl intravenous, Fentanyl intranasal using atomizer, fentanyl intranasal direct.
- Who it may be relevant to
- Registry conditions: Procedural Pain. Basic parameters: up to 28 Days · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Intranasal Versus Intravenous Fentanyl For Procedural Analgesia in Preterm Neonates : A Randomized Controlled Trial
Overview
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.
Interventions
- 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
Primary outcome measures
- procedural pain managment [Time frame: from giving the fentanyl before the procedure till one hour after .]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Egypt · 1 center
- Ain Shams University — Cairo
Identifiers
NCT: NCT07190625 · FMASU MD342/2023