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New combo drug may cut painkiller use in ventilated newborns

NCT ID NCT07241351

Symptom relief Sponsor: Ain Shams University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether adding dexmedetomidine (a sedative) to fentanyl (a painkiller) could reduce the amount of fentanyl needed for full-term newborns on breathing machines. Forty babies were given either a lower fentanyl dose plus dexmedetomidine or standard fentanyl alone. Researchers tracked pain scores and how many extra painkiller doses were needed, while watching for side effects like slow heart rate or low blood pressure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Dexmedetomidine (a sedative) and fentanyl (a painkiller)
What this could lead to
If it works, this could help reduce the amount of fentanyl needed for newborns on breathing machines, potentially lowering side effects.
What could go wrong
This is a small, early-phase study with only 40 babies. It may not show clear benefits, and risks like slow heart rate or low blood pressure are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

40 people

The number who actually took part.

Started

Mar 2024

Finished

Jul 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 hour to 28 days

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Full term neonates (≥ 37 weeks gestational age) * Age: 1 to 28 days. * Neonates just started invasive mechanical ventilation and are going to start sedation. Exclusion Criteria: * Presence of central nervous system abnormality * Complex multiple congenital anomalies * Neonates with facial malformations * Neonates on mechanical Ventilation setting (peep above 9)

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Conditions

The condition(s) this trial relates to.

agnosia pain agnosia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Analgesia Mechanical ventilation in neonates Neonatal Sedation and analgesia

Contacts and locations

Locations

  • Ain Shams University Hospitals

    Cairo, Egypt

More trials for these conditions

Other studies related to the condition(s) this trial covers.