Procedural PainEarly Phase 1NCT07190625
Intranasal Versus Intravenous Fentanyl For Procedural Analgesia in Preterm Neonates
A Early Phase 1 study testing fentanyl intravenous, Fentanyl intranasal using atomizer and fentanyl intranasal direct in people with Procedural Pain, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Procedural Pain
- What is being tested?
- fentanyl intravenous, Fentanyl intranasal using atomizer and fentanyl intranasal direct
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Dec 2023to 1 Jun 2026
- Phase
- Early Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rabab Gameel Allam, MD contact
About this study
Official title: Intranasal Versus Intravenous Fentanyl For Procedural Analgesia in Preterm Neonates : A Randomized Controlled 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.
Read the 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.
- 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
- Being tested
- fentanyl intravenous, Fentanyl intranasal using atomizer, fentanyl intranasal direct
- Medical subject headings
- Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fentanyl intravenousDrug
giving intravenous fentanyl
Fentanyl intranasal using atomizerDrug
giving intranasal fentanyl using nasal atomizer
fentanyl intranasal directDrug
giving intranasal fentanyl directly into nostrils
| Study group | Role | What they receive |
|---|---|---|
| intravenous group | Active comparator | this group of neonates will recieve intravenous fentanyl during procedure Receives: Drug: fentanyl intravenous |
| direct intranasal group | Active comparator | this group of neonates will recieve direct intranasal fentanyl during procedure Receives: Drug: fentanyl intranasal direct |
| nasal atomizer group | Active comparator | this group of neonates will recieve intranasal fentanyl with atomizer during procedure Receives: Drug: Fentanyl intranasal using atomizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from giving the fentanyl before the procedure till one hour after .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start24 Dec 2023
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Passant Fahmy, M.Sc, Principal investigator, Assisstant lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07190625
- Sponsor's protocol ID
- FMASU MD342/2023
- Status last verified
- Aug 2025
- First submitted
- 5 Sep 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided