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NCT05500599
Effects on Recovery of Children of Intravenous Formulation of Fentanyl Citrate and Midazolam Orally for Premedication
NA trial testing Fentanyl Citrate in Separation Anxiety in 60 participants. Participants enrolled and being followed up; not accepting new ones.
31 May 2025
Quick facts
| Lead sponsor | Alexandria University |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | supportive care |
| Enrollment | 60 |
| Start date | 1 March 2022 |
| Primary completion | 31 May 2025 |
| Estimated completion | 28 August 2025 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- Fentanyl Citrate — full drug profile →
Conditions studied
- Separation Anxiety — all drugs for Separation Anxiety →
Sponsor
Alexandria University
Who can join
Adults 2 to 8, any sex, with Separation Anxiety. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To study and compare the efficacy of intravenous formula of fentanyl citrate and midazolam administered orally for premedication in paediatric surgical patients. Primary objectives will be the effect of both premedicants on recovery. The secondary outcomes will be time of onset and level of sedation, acceptance of premedication, and adverse effects. Sixty paediatric patients of either sex, in the age group of 2-8 years, with the American Society of Anaesthesiologists (ASA) Physical status I, posted for elective Genito-urological surgeries under general anaesthesia (GA) will be studied after clearance from the Institutional Ethics Committee and after obtaining written informed consent from a parent or a legal guardian
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05500599
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Related trials
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Trials testing the same drug.
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- NCT04645823 — Spinal Fentanyl or Epidural Analgesia in the Early First Phase of Induced Labor · Phase 4 · completed
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Other recruiting trials for Separation Anxiety
Currently open trials in the same condition.
- NCT06934525 — Implementing Team-Based Treatment for Pediatric Anxiety in Community Mental Health Settings · NA · recruiting
- NCT05967468 — Evaluation of Family-Based Behavioral Treatments for Youth With Anxiety and Obsessive-Compulsive Disorder · NA · active not recruiting
Other Alexandria University trials
Trials by the same sponsor.
- NCT07517861 — Integrated Mental Health Nursing Program: Effects on Stigma, Cognitive Flexibility, and Clinical Readiness · NA · recruiting
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- NCT07503626 — Optimization of Orthodontic Bracket Placement by Using Two Different Protocols of Digitally Aided Bonding · NA · recruiting
- NCT07522944 — AI-Guided Relaxation for Hemodialysis Anxiety · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05500599 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Alexandria University
- Last refreshed: 29 November 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05500599.
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