Trial · NCT07900321
Equivalence of Oral Melatonin and Oral Midazolam in Preoperative Anxiolysis for Pediatric Fast-Track Cardiac Surgery
NCT07900321, Phase 2, Phase 3, Active not recruiting, Ain Shams University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Equivalence of Oral Melatonin and Oral Midazolam in Preoperative Anxiolysis for Pediatric Fast-Track Cardiac Surgery. Trials, record NCT07900321. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07900321
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Equivalence of Oral Melatonin and Oral Midazolam in Preoperative Anxiolysis for Pediatric Fast-Track Cardiac Surgery
- NCT number
- NCT07900321
- Status
- Active not recruiting
- Phases
- Phase 2, Phase 3
- Enrollment
- 100 participants, estimated
- Lead sponsor
- Ain Shams University
- Conditions
- Comparative Effectiveness
- Interventions
- Melatonin, Midazolam
- First posted
- 2026-10-28
- Last updated
- 2026-10-28
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Child separation behavior | 20 minutes after drug administration | Evaluated using Child-Parent Separation Score of 4 grades, higher score means difficult separation |
| Primary | Preoperative anxiety | 20 minutes after drug administration and upon OR arrival | Measured using Yale preoperative Anxiety scale |
| Secondary | Drug acceptance between melatonin and midazolam | baseline, time of oral drug administration | regarding each drug taste, score of 3 which 3 means unpleasant taste |
| Secondary | Sedation level | 20 minutes after drug administration and upon OR arrival | Assesed by University of Michigan sedation scale, score of 4 which 4 means unarousable |
| Secondary | Post operative emergance agitation | Post extubation ranging from immediate post operative extubation to 2 hours postoperative | Assessed by Richmond Agitation-Sedation Scale ranging from -5 which means unarousable to +4 which means combative |
| Secondary | Post operative emergance delirium | initial assesment ( T0) at the moment of awakening ,, then every 10 minutes for 1 hour | Using Pediatric Anesthesia Emergance Delirium Scale ,ranging from 0 to 20 where 0 eans calm and agitation considered if score more than 10 |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07900321
GET https://conductscience.org/api/trials/v1/NCT07900321/registered