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

Comparison of Nebulized Fentanyl, Midazolam and Dexmedetomidine as a Sedative Premedication in Outpatient Pediatric Dental Surgeries : A Randomized Double Blind Study.

• 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.

Study Overview

• Status: Completed
• Conditions: Dental Surgeries
• Intervention / Treatment: Drug: fentanyl; Drug: midazolam; Drug: dexmedetomidine

Detailed Description

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(1). Parentral separation and needle injection increase preoperative anxiety. Preoperative stress response stimulates the sympathetic, parasympathetic, and endocrine systems, leading to an increase in heart rate (HR), blood pressure, and cardiac excitability(2,3) . Dental procedures are assiociated by high rate of fear and anxiety in children (4).

Many drugs have been used as premedication to decrease anxiety , facilitate smooth induction and easy separation of children from their parents. The ideal premedication especially in children must be acceptable with rapid onset ,minimal side effects and with rapid postoperative recovery and return to alertness (5,6).

Fentanyl is a potent analgesic opioid with a rapid onset, and short duration of action (7). Midazolam is a short-acting benzodiazepine that has anxiolytic, amnestic, hypnotic, anticonvulsant and muscle relaxant actions (8,9). Dexmedetomidine is a selective α-2 adrenergic agonist that has both sedative and analgesic effects (10-12)

Preoperative sedation in children is usually administered via the rectal, oral sublingual, and intranasal routes with different degrees of patient acceptance.(13-18). Nebulized drug is an alternative method of sedation that is relatively easy to set up, without need for venipuncture, and is associated with high bioavailability of the drug (19,20).

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. The primary end point is the time of sedation and level of sedation when the child is first seen in the operating room(OR) 30 minutes after using studied drugs, based on the Modified Observer's Assessment of Alertness/Sedation Scale(19). The secondary end points are parentral separation, tolerance to mask induction, reaction to intravenous cannulation, hemodynamic changes( systolic blood pressure, diastolic blood pressure and heart rate), sedation at emergence and wake-up behavior.

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Zagazig, Elsharkia,egypt
    • Zagazig, Zagazig, Elsharkia,egypt, Egypt, 44519
      • Faculty of Medicine,Zagazig University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 6 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: fentanyl; patients will be given nebulized fentanyl 2μg/kg body weight 30 min before surgery	Drug: fentanyl; nebulized fentanyl 2μg/kg body weigh; Other Names: fentanyl,
ACTIVE_COMPARATOR: midazolam; The patients will be given nebulized midazolam 0.2 mg/kg body weight 30 min before surgery.	Drug: midazolam; nebulized midazolam 0.2 mg/kg body weight 30 min before surgery.; Other Names: dormicum
ACTIVE_COMPARATOR: dexmedetomidine; The patients will be given nebulized dexmedetomidine 2 μg/kg body weight 30 min before surgery.	Drug: dexmedetomidine; nebulized dexmedetomidine 2 μg/kg body weight 30 min before surgery.; Other Names: precedex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	hemodynamic changes	Baseline (before surgery) and intraoperative
systolic and diastolic blood pressure	hemodynamic changes	Baseline (before surgery) and intraoperative

Collaborators and Investigators

• Sponsor: Zagazig University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2019
• Primary Completion (ACTUAL): January 20, 2021
• Study Completion (ACTUAL): April 20, 2021

Study Registration Dates

• First Submitted: January 5, 2020
• First Submitted That Met QC Criteria: January 10, 2020
• First Posted (ACTUAL): January 13, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 21, 2021
• Last Update Submitted That Met QC Criteria: April 19, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: fentanyl ,midazolam, dexmeditomidine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Fentanyl; Midazolam; Dexmedetomidine
• Other Study ID Numbers: 5742-3-12-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: planned after completion of the study and publication
• IPD Sharing Time Frame: planned after completion of the study and publication
• IPD Sharing Access Criteria: contact after pricipal investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No