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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Versus Intravenous Fentanyl For Procedural Analgesia in Preterm Neonates : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07190625
- Acronym / sponsor ID
- FMASU MD342/2023
- Conditions
- Procedural Pain
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 24 Dec 2023 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 24 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| intravenous group | Active comparator | Drug: fentanyl intravenousthis group of neonates will recieve intravenous fentanyl during procedure |
| direct intranasal group | Active comparator | Drug: fentanyl intranasal directthis group of neonates will recieve direct intranasal fentanyl during procedure |
| nasal atomizer group | Active comparator | Drug: Fentanyl intranasal using atomizerthis group of neonates will recieve intranasal fentanyl with atomizer during procedure |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fentanyl intravenousgiving intravenous fentanyl | Drug | intravenous group |
| Fentanyl intranasal using atomizergiving intranasal fentanyl using nasal atomizer | Drug | nasal atomizer group |
| fentanyl intranasal directgiving intranasal fentanyl directly into nostrils | Drug | direct intranasal group |
Primary outcome
procedural pain managment
Time frame: from giving the fentanyl before the procedure till one hour after .
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: Undecided
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Soap-and-Water Bed Bath Versus Disposable Wipe Bath in the Same ICU Patients
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rabab Gameel Allam, MD contact
Passant Fahmy, M.Sc principal investigator
Assisstant lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Passant Osama Fahmy, M.Sc (01066724641, Passant.Osama@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
procedural pain managment (time frame: from giving the fentanyl before the procedure till one hour after .). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.