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Could Opioid-Free pain relief be safer for kids with sleep apnea?

NCT ID NCT07435493

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares standard fentanyl pain medicine to an opioid-free mix of acetaminophen, ibuprofen, ketamine, and dexamethasone in 64 children aged 5-10 with mild to moderate sleep apnea undergoing tonsil surgery. The goal is to see if the opioid-free option controls pain just as well but with fewer breathing problems and side effects.

What this could mean

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

Active substance
fentanyl, acetaminophen, ibuprofen, ketamine, dexamethasone
What this could lead to
If successful, this could show that a combination of non-opioid drugs can control pain safely in children with sleep apnea, reducing breathing complications.
What could go wrong
This is a small, early-stage trial with only 64 children, so results may not apply to all. The opioid-free approach might not control pain as well as fentanyl.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 64 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

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

5 to 10 years

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: * Children aged 5-10 years. * Diagnosed with mild to moderate Obstructive Sleep Apnea (apnea-hypoxia index 1-10). * Scheduled for elective adenotonsillectomy. * American Society of Anesthesiologists physical status I-II. Exclusion Criteria: * Severe Obstructive Sleep Apnea (apnea-hypoxia index \>10). * Known allergies to study medications. * Patient with predicted difficult air way (Mallampatti 3\&4). * History of opioid use or chronic pain syndromes. * Neurological or metabolic disorders affecting pain perception. * Parental refusal to consent.

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Conditions

The condition(s) this trial relates to.

obstructive sleep apnea syndrome

As listed by the trial registrant

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

Adenotonsillectomy Fentanyl Obstructive sleep apnea (OSA) OPIOID

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ain shams university

    Cairo, Egypt

More trials for these conditions

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