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

NCT05500599 | Active Not Recruiting DMC

• 1 other identifier: 0305335
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Separation Anxiety

Keywords

recovery; Anxiety; Fentanyl; midazolam; Premedication

Outcome Measures

Primary Outcomes (1)

• effect of both premedicants on recovery

  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

  immediately after the surgery average 2 hours postoperative

Secondary Outcomes (3)

• time of onset and level of sedation,

  Before the surgery starts

• acceptance of premedication

  after ingestion of the premedication and before the surgery starts

• Time to recovery

  immediately after the surgery average 2 hours postoperative

Study Arms (2)

midazolam (Group M)

NO INTERVENTION

receive 0.5 mg/kg midazolam orally approximately 30 min before the induction of anaesthesia

fentanyl (Group F)

ACTIVE COMPARATOR

receive 10 μg/kg fentanyl orally approximately 30 min before the induction of anaesthesia

Drug: Fentanyl Citrate

Interventions

Fentanyl Citrate DRUG

Intravenous Formulation of Fentanyl Citrate and Midazolam Administered Orally for Premedication

Also known as: Midazolam

fentanyl (Group F)

Eligibility Criteria

• Age: 2 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• (ASA) Physical status I,
• posted for elective Genito-urological surgeries under general anaesthesia (GA)

You may not qualify if:

• 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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Ahmed S. Shehab

Alexandria, Alexandria Governorate, 21431, Egypt

Location

Related Publications (1)

• Bergendahl H, Lonnqvist PA, Eksborg S. Clonidine in paediatric anaesthesia: review of the literature and comparison with benzodiazepines for premedication. Acta Anaesthesiol Scand. 2006 Feb;50(2):135-43. doi: 10.1111/j.1399-6576.2006.00940.x.

  PMID: 16430532 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Anxiety, Separation; Anxiety Disorders

Interventions

Fentanyl; Midazolam

Condition Hierarchy (Ancestors)

Mental Disorders; Neurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Ahmed S. Shehab

  Alexandria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double blinded
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer Of Anaesthesia and Surgical intensive care

Model Details: All children will be randomized to one of two groups of thirty patients each according to a computer-generated random numbers program in a double-blinded fashion, to receive either 0.5 mg/kg midazolam (Group M) or 10 μg/kg fentanyl (Group F) approximately 30 min before the induction of anaesthesia. All observers, as well as the children and their parents, will be blind to the study drug administered.

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: August 15, 2022
• Study Start: March 1, 2022
• Primary Completion: May 31, 2025
• Study Completion: August 28, 2025
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After study ends upon request
• Access Criteria: Accessible through the web site

Locations

EG (1)