Comparative EffectivenessPhase 2/3NCT07900321
Equivalence of Oral Melatonin and Oral Midazolam in Preoperative Anxiolysis for Pediatric Fast-Track Cardiac Surgery
A Phase 2/3 study testing Melatonin and Midazolam in people with Comparative Effectiveness, run by Ain Shams University at 1 site in Egypt.
Trial summary
Equivalence of Oral Melatonin and Oral Midazolam in Preoperative Anxiolysis for Pediatric Fast-Track Cardiac Surgery Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Comparative Effectiveness
- What is being tested?
- Melatonin and Midazolam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2025to 1 Dec 2026
- Phase
- Phase 2/3
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- pediatics undergoing Fast-track congenital cardiac surgery ASA 2 Informed parental consent
Who cannot join
- history of psychiatric illness History of used drug allergy Sever hepatic or renal disease Emergancy surgery Developmental or neurological disorder
Trial locations and contacts
1 site in 1 country.
About this study
Equivalence of Oral Melatonin and Oral Midazolam in Preoperative Anxiolysis for Pediatric Fast-Track Cardiac Surgery
Read the detailed description
Comparision between two oral drugs preoperative for pediatrics to reach a result of anxiolysis and decrease separation anexity .
- Conditions
- Comparative Effectiveness
- Keywords
- Comparision between two drugs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
A group of patients will recieve oral melatonin and the other group will recieve oral midazolam
MidazolamDrug
One group will recieve oral melatonin and the other will recieve oral midazolam
| Study group | Role | What they receive |
|---|---|---|
| Melatonin group | Active comparator | Drug: oral melatonin Receives: Drug: Melatonin |
| Medazolam group | Active comparator | Drug : oral midazolam Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child separation behavior
Evaluated using Child-Parent Separation Score of 4 grades, higher score means difficult separation
Measured: 20 minutes after drug administration
Preoperative anxiety
Measured using Yale preoperative Anxiety scale
Measured: 20 minutes after drug administration and upon OR arrival
Secondary outcomes (4)
Drug acceptance between melatonin and midazolam
regarding each drug taste, score of 3 which 3 means unpleasant taste
Measured: baseline, time of oral drug administration
Sedation level
Assesed by University of Michigan sedation scale, score of 4 which 4 means unarousable
Measured: 20 minutes after drug administration and upon OR arrival
Post operative emergance agitation
Assessed by Richmond Agitation-Sedation Scale ranging from -5 which means unarousable to +4 which means combative
Measured: Post extubation ranging from immediate post operative extubation to 2 hours postoperative
Post operative emergance delirium
Using Pediatric Anesthesia Emergance Delirium Scale ,ranging from 0 to 20 where 0 eans calm and agitation considered if score more than 10
Measured: initial assesment ( T0) at the moment of awakening ,, then every 10 minutes for 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start1 Nov 2025
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Comparative EffectivenessStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07900321
- Sponsor's protocol ID
- FMASU MD276/2025
- Status last verified
- Apr 2026
- First submitted
- 18 Apr 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Equivalence of Oral Melatonin and Oral Midazolam in Preoperative Anxiolysis for Pediatric Fast-Track Cardiac Surgery
- ClinicalTrials.gov ID
- NCT07900321
- Acronym / sponsor ID
- FMASU MD276/2025
- Conditions
- Comparative Effectiveness
- Keywords
- Comparision between two drugs
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 28 Oct 2026 (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.
Equivalence of Oral Melatonin and Oral Midazolam in Preoperative Anxiolysis for Pediatric Fast-Track Cardiac Surgery
Detailed description
Comparision between two oral drugs preoperative for pediatrics to reach a result of anxiolysis and decrease separation anexity .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melatonin group | Active comparator | Drug: MelatoninDrug: oral melatonin |
| Medazolam group | Active comparator | Drug: MidazolamDrug : oral midazolam |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- pediatics undergoing Fast-track congenital cardiac surgery ASA 2 Informed parental consent
Key exclusion criteria (1 listed)
- history of psychiatric illness History of used drug allergy Sever hepatic or renal disease Emergancy surgery Developmental or neurological disorder
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 |
|---|---|---|
| MelatoninA group of patients will recieve oral melatonin and the other group will recieve oral midazolam | Drug | Melatonin group |
| MidazolamOne group will recieve oral melatonin and the other will recieve oral midazolam | Drug | Medazolam group |
Primary outcome
Child separation behavior
Time frame: 20 minutes after drug administration
Evaluated using Child-Parent Separation Score of 4 grades, higher score means difficult separation
Preoperative anxiety
Time frame: 20 minutes after drug administration and upon OR arrival
Measured using Yale preoperative Anxiety scale
4 secondary outcomes
Drug acceptance between melatonin and midazolam
Time frame: baseline, time of oral drug administration
Sedation level
Time frame: 20 minutes after drug administration and upon OR arrival
Post operative emergance agitation
Time frame: Post extubation ranging from immediate post operative extubation to 2 hours postoperative
Post operative emergance delirium
Time frame: initial assesment ( T0) at the moment of awakening ,, then every 10 minutes for 1 hour
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 28 Oct 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Melatonin and Midazolam in people with Comparative Effectiveness, 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 28 Oct 2026. 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?
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?
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?
Child separation behavior (time frame: 20 minutes after drug administration). 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 28 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.