Active — Not RecruitingNot Applicable

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

Egypt60 participantsStarted 2022-03-01

Plain-language 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

Who can participate

Age range2 Years – 8 Years

SexALL

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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

What they're measuring

effect of both premedicants on recovery

Timeframe: immediately after the surgery average 2 hours postoperative

Trial details

NCT IDNCT05500599

SponsorAlexandria University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-31

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