Clinical trial NCT04226885: Comparison of Nebulized Fentanyl, Midazolam and Dexmedetomidine as a Premedication in Pediatric Dental Surgeries
Official title: Comparison of Nebulized Fentanyl, Midazolam and Dexmedetomidine as a Sedative Premedication in Outpatient Pediatric Dental Surgeries : A Randomized Double Blind Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Surgeries
Keywords: fentanyl ,midazolam, dexmeditomidine
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2020-01-13
Enrollment: 39
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: of onset of sedation
timeFrame: Baseline (before surgery)
Secondary outcomes:
measure: Heart rate
timeFrame: Baseline (before surgery) and intraoperative
measure: systolic and diastolic blood pressure
timeFrame: Baseline (before surgery) and intraoperative
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Faculty of Medicine,Zagazig University
state: Zagazig, Elsharkia,egypt
Study officials:
References: