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Clinical Trials in Egypt / NCT05500599
Active, not recruiting Not applicable

Effects on Recovery of Children of Intravenous Formulation of Fentanyl Citrate and Midazolam Orally for Premedication

NCT05500599 · tracked via the Priya Life Science Egypt tracker
Sponsor
Alexandria University
Phase
Not applicable
Started
2022-03-01
Last updated
2024-11-29

Condition(s) studied

Separation Anxiety

Investigational drug(s) / intervention(s)

Fentanyl Citrate →

Fentanyl Citrate: Intravenous Formulation of Fentanyl Citrate and Midazolam Administered Orally for Premedication

Study summary

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

Eligibility

Sex
ALL
Min age
2 Years
Max age
8 Years
Healthy volunteers
No
Inclusion Criteria: * (ASA) Physical status I, * posted for elective Genito-urological surgeries under general anaesthesia (GA) Exclusion Criteria: * known allergy to fentanyl or midazolam, * intellectual and developmental disabilities, * psychosomatic disorders, * history of any sedative or analgesic intake, * ASA physical status ≥ 2, * upper respiratory tract infection, * history of previous surgery, * being accompanied by a non-family member

Primary outcome measure(s)

  • effect of both premedicants on recovery — immediately after the surgery average 2 hours postoperative
    1\. The quality of recovery will be evaluated using the three objective components in the modified pain/discomfort scale. Each variable scoring 0-2 points (best to worst). If the total score on the pain/discomfort scale at any evaluation point exceeded 3, the child will be regarded as suffering from postanaesthetic excitement. score 0 1 2 Crying Not crying Responding to pain Not responding to comforting Moving None Restless Thrashing Agitation Asleep/calm Mild agitation Sever agitation/Hysterical

Trial sites (1)

FacilityCityRegionStatus
Ahmed S. Shehab Alexandria Alexandria Governorate

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05500599 on ClinicalTrials.gov ↗ ← All trials in Egypt