AnalgesiaPhase 2/3NCT07241351
Dexmedetomidine as an Adjunct to Fentanyl for Term Neonates on Mechanical Ventilation
A Phase 2/3 study testing Dexmedetomidine, fentanyl 1mcg/kg/hr and fentanyl 0.5 mcg/kg/hr in people with Analgesia and Sedation and Analgesia, run by Ain Shams University at 1 site in Egypt.
Trial summary
Despite well conducted studies on pain management in mechanically ventilated neonates, there is still a need for exploration of appropriate and accurate pharmacological management strategies for this ongoing pain, and assessment of the clinical impact of the used drugs for analgesia and sedation. Read more about this study
- Who is it for?
- Ages 1 hour to 28 days
- Conditions the study is for
- Analgesia, Sedation and Analgesia, Neonatal
- What is being tested?
- Dexmedetomidine, fentanyl 1mcg/kg/hr and fentanyl 0.5 mcg/kg/hr
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2024to 1 Jul 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 1 hour to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Full term neonates (≥ 37 weeks gestational age)
- Age: 1 to 28 days.
- Neonates just started invasive mechanical ventilation and are going to start sedation.
Who cannot join
- Presence of central nervous system abnormality
- Complex multiple congenital anomalies
- Neonates with facial malformations
- Neonates on mechanical Ventilation setting (peep above 9)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dexmedetomidine as an Adjunct to Fentanyl for Analgesia and Sedation of Term Neonates on Mechanical Ventilation
Despite well conducted studies on pain management in mechanically ventilated neonates, there is still a need for exploration of appropriate and accurate pharmacological management strategies for this ongoing pain, and assessment of the clinical impact of the used drugs for analgesia and sedation.
In the current study, the aim was to reduce fentanyl doses on mechanical ventilated neonates after adding Dexmedetomidine
Read the detailed description
Despite well conducted studies on pain management in mechanically ventilated neonates, there is still a need for exploration of appropriate and accurate pharmacological management strategies for this ongoing pain, and assessment of the clinical impact of the used drugs for analgesia and sedation. Opioids, such as fentanyl, are frequently used for analgesia and sedation in mechanically ventilated neonates with their short- and long-term adverse consequences Dexmedetomidine (DEX) is a specific alpha2 adrenergic agonist with promising data in NICU. Data exist that Dexmedetomidine recipient neonates require less adjunct sedation, experience less respiratory depression, less clinically significant hemodynamic effects, quicker establishment of enteral feeds and they could be extubated whilst on Dexmedetomidine infusion.
In the current study, the aim was to reduce fentanyl doses on mechanical ventilated neonates after adding Dexmedetomidine
- Being tested
- Dexmedetomidine, fentanyl 1mcg/kg/hr, fentanyl 0.5 mcg/kg/hr
- Keywords
- sedation, analgesia, full term neonates, dexmedetomidine, fentanyl, adjuvant
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
administration of DEX continuous IV infusion, over 24 hours, at a maintenance dose of 0.3 mcg/kg/hr for neonates <14 days and 0.5 mcg/kg/hr for those ≥14 days postnatal age
fentanyl 1mcg/kg/hrDrug
fentanyl as continuous infusion at 1.0 mcg/kg/hr over 24 hours
fentanyl 0.5 mcg/kg/hrDrug
fentanyl as a continuous infusion dose of 0.5 mcg/kg/hr over 24 hours with concomitant
| Study group | Role | What they receive |
|---|---|---|
| dexmedetomidine and fentanyl | Experimental | fentanyl as a continuous infusion dose of 0.5 mcg/kg/hr over 24 hours with concomitant administration of DEX continuous IV infusion, over 24 hours, at a maintenance dose of 0.3 mcg/kg/hr for neonates <14 days and 0.5 mcg/kg/hr for those ≥14 days postnatal age Receives: Drug: Dexmedetomidine; Drug: fentanyl 0.5 mcg/kg/hr |
| fentanyl only | Active comparator | fentanyl as continuous infusion at 1.0 mcg/kg/hr over 24 Receives: Drug: fentanyl 1mcg/kg/hr |
What is being measured
The primary outcome is the main question the study is designed to answer.
need for additional rescue analgesia
number of doses of rescue analgesia given during the first 24 hours
Measured: 24 hours
NPASS ( neonatal pain , agitation and sedation score)
done hourly to indicate pain and sedation if more than or equal to three patient is in pain
Measured: 24 hours
Secondary outcomes (3)
development of bradycardia,
development of bradycardia,
Measured: 24 hours
development of hypotension
development of hypotension
Measured: 24 hours
development of respiratory depression
development of respiratory depression
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start1 Mar 2024
- Primary completion1 Nov 2024
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies 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
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Ibrahim, Ain Shams University
- Investigators
- mariam JA ibrahim, PHD, Principal investigator, Ain Shams UniversityRouzan A Nassar, MBBCH, Principal investigator, MOHP Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07241351
- Sponsor's protocol ID
- Dexmedetomidine as an Adjunct
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: data can be shared from the corresponding author upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine as an Adjunct to Fentanyl for Analgesia and Sedation of Term Neonates on Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT07241351
- Acronym / sponsor ID
- Dexmedetomidine as an Adjunct
- Keywords
- sedation, analgesia, full term neonates, dexmedetomidine, fentanyl, adjuvant
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 21 Nov 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.
Despite well conducted studies on pain management in mechanically ventilated neonates, there is still a need for exploration of appropriate and accurate pharmacological management strategies for this ongoing pain, and assessment of the clinical impact of the used drugs for analgesia and sedation.
In the current study, the aim was to reduce fentanyl doses on mechanical ventilated neonates after adding Dexmedetomidine
Detailed description
Despite well conducted studies on pain management in mechanically ventilated neonates, there is still a need for exploration of appropriate and accurate pharmacological management strategies for this ongoing pain, and assessment of the clinical impact of the used drugs for analgesia and sedation. Opioids, such as fentanyl, are frequently used for analgesia and sedation in mechanically ventilated neonates with their short- and long-term adverse consequences Dexmedetomidine (DEX) is a specific alpha2 adrenergic agonist with promising data in NICU. Data exist that Dexmedetomidine recipient neonates require less adjunct sedation, experience less respiratory depression, less clinically significant hemodynamic effects, quicker establishment of enteral feeds and they could be extubated whilst on Dexmedetomidine infusion.
In the current study, the aim was to reduce fentanyl doses on mechanical ventilated neonates after adding Dexmedetomidine
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexmedetomidine and fentanyl | Experimental | Drug: Dexmedetomidine, Drug: fentanyl 0.5 mcg/kg/hrfentanyl as a continuous infusion dose of 0.5 mcg/kg/hr over 24 hours with concomitant administration of DEX continuous IV infusion, over 24 hours, at a maintenance dose of 0.3 mcg/kg/hr for neonates <14 days and 0.5 mcg/kg/hr for those ≥14 days postnatal age |
| fentanyl only | Active comparator | Drug: fentanyl 1mcg/kg/hrfentanyl as continuous infusion at 1.0 mcg/kg/hr over 24 |
Who may qualify
- Ages
- 1 hour to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Full term neonates (≥ 37 weeks gestational age)
- Age: 1 to 28 days.
- Neonates just started invasive mechanical ventilation and are going to start sedation.
Key exclusion criteria (4 listed)
- Presence of central nervous system abnormality
- Complex multiple congenital anomalies
- Neonates with facial malformations
- Neonates on mechanical Ventilation setting (peep above 9)
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 |
|---|---|---|
| Dexmedetomidineadministration of DEX continuous IV infusion, over 24 hours, at a maintenance dose of 0.3 mcg/kg/hr for neonates <14 days and 0.5 mcg/kg/hr for those ≥14 days postnatal age | Drug | dexmedetomidine and fentanyl |
| fentanyl 1mcg/kg/hrfentanyl as continuous infusion at 1.0 mcg/kg/hr over 24 hours | Drug | fentanyl only |
| fentanyl 0.5 mcg/kg/hrfentanyl as a continuous infusion dose of 0.5 mcg/kg/hr over 24 hours with concomitant | Drug | dexmedetomidine and fentanyl |
Primary outcome
need for additional rescue analgesia
Time frame: 24 hours
number of doses of rescue analgesia given during the first 24 hours
NPASS ( neonatal pain , agitation and sedation score)
Time frame: 24 hours
done hourly to indicate pain and sedation if more than or equal to three patient is in pain
3 secondary outcomes
development of bradycardia,
Time frame: 24 hours
development of hypotension
Time frame: 24 hours
development of respiratory depression
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: Yes. data can be shared from the corresponding author upon reasonable request
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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. This study is not recruiting at the moment.
mariam JA ibrahim, PHD principal investigator
Ain Shams University
Rouzan A Nassar, MBBCH principal investigator
MOHP Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dexmedetomidine, fentanyl 1mcg/kg/hr and fentanyl 0.5 mcg/kg/hr in people with Analgesia and Sedation and Analgesia, 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 2 Dec 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
need for additional rescue analgesia (time frame: 24 hours). The study lists 2 primary outcomes in all. 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 2 Dec 2025.