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

NCT ID: NCT04226885

Last Updated: 2021-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2021-04-20

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.

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.

Conditions

Dental Surgeries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

fentanyl

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

Group Type: ACTIVE_COMPARATOR

fentanyl

Intervention Type: DRUG

nebulized fentanyl 2μg/kg body weigh

midazolam

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

Group Type: ACTIVE_COMPARATOR

midazolam

Intervention Type: DRUG

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

dexmedetomidine

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

Group Type: ACTIVE_COMPARATOR

dexmedetomidine

Intervention Type: DRUG

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

Interventions

fentanyl

nebulized fentanyl 2μg/kg body weigh

Intervention Type: DRUG

midazolam

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

Intervention Type: DRUG

dexmedetomidine

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

Intervention Type: DRUG

Other Intervention Names

fentanyl,; dormicum; precedex

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Marwa Mohamed Medhat

lecture of anesthesia and surgical intensive care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Medicine,Zagazig University

Zagazig, Zagazig, Elsharkia,egypt, Egypt

Countries

Egypt

Other Identifiers

5742-3-12-2019

Identifier Type: -

Identifier Source: org_study_id