Comparison of Nebulized Fentanyl, Midazolam and Dexmedetomidine as a Premedication in Pediatric Dental Surgeries

NCT04226885 | Completed

• 1 other identifier: 5742-3-12-2019
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

• The preoperative time can be traumatic for young children undergoing surgery. Pediatric anesthesiologists act strongly to decrease distress for children in the operating room (OR) and to provide a smooth induction of anesthesia.
• Many drugs have been used as premedication to decrease anxiety , facilitate smooth induction and easy separation of children from their parents.
• This study was designed to evaluate and compare the effect and safety of nebulized either fentanyl, midazolam or nebulized dexmedetomidine as a sedative premedication prior to general anesthesia (GA) in outpatient pediatric dental surgeries.

Conditions

Dental Surgeries

Keywords

fentanyl ,midazolam, dexmeditomidine

Outcome Measures

Primary Outcomes (1)

• of onset of sedation

  onset of sedation based on the Modified Observer's Assessment of Alertness/Sedation Scale 6Appears alert and awake, responds readily to name spoken in normal tone 5 Appears asleep but responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly or repeatedly 2 Responds only after mild prodding or shaking 1 Does not respond to mild prodding or shaking 0 Does not respond to noxious stimulus

  Baseline (before surgery)

Secondary Outcomes (2)

• Heart rate

  Baseline (before surgery) and intraoperative

• systolic and diastolic blood pressure

  Baseline (before surgery) and intraoperative

Study Arms (3)

fentanyl

ACTIVE COMPARATOR

patients will be given nebulized fentanyl 2μg/kg body weight 30 min before surgery

Drug: fentanyl

midazolam

ACTIVE COMPARATOR

The patients will be given nebulized midazolam 0.2 mg/kg body weight 30 min before surgery.

Drug: midazolam

dexmedetomidine

ACTIVE COMPARATOR

The patients will be given nebulized dexmedetomidine 2 μg/kg body weight 30 min before surgery.

Drug: dexmedetomidine

Interventions

fentanyl DRUG

nebulized fentanyl 2μg/kg body weigh

Also known as: fentanyl,

fentanyl

midazolam DRUG

nebulized midazolam 0.2 mg/kg body weight 30 min before surgery.

Also known as: dormicum

midazolam

dexmedetomidine DRUG

nebulized dexmedetomidine 2 μg/kg body weight 30 min before surgery.

Also known as: precedex

dexmedetomidine

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Parent acceptance.Children 2-6 years old of either sex.12-18 kg body weight. american society of anesthesiologist I-II.outpatients dental surgeries under general anesthesia.

You may not qualify if:

• Difficult airway .central nervous system dysfunction.Advanced Cardiovascular ,liver, renal diseases. Allergy to the drugs under study. Patients with any intranasal pathology or congenital anomaly.Patient refusal to take the inhaled premeditation.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Faculty of Medicine,Zagazig University

Zagazig, Zagazig, Elsharkia,egypt, 44519, Egypt

Location

MeSH Terms

Interventions

Fentanyl; Midazolam; Dexmedetomidine

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecture of anesthesia and surgical intensive care

Study Record Dates

• First Submitted: January 5, 2020
• First Posted: January 13, 2020
• Study Start: March 1, 2019
• Primary Completion: January 20, 2021
• Study Completion: April 20, 2021
• Last Updated: April 21, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: planned after completion of the study and publication
• Access Criteria: contact after pricipal investigator

Locations

EG (1)