Intranasal Dexmedetomidine in Children Undergoing Adenotonsillectomy Suffering From Mild Upper Respiratory Tract Infection

Tanta University

Status and phase: Enrolling; Phase 4

Conditions: Adenotonsillectomy; Dexmedetomidine; Respiratory Tract Infections

Treatments: Drug: Dexmedetomidine group; Other: control group

Study type: Interventional

Funder types: Other

Identifiers

NCT05639777

35355/3/22

Details and patient eligibility

About

The purpose of this study is to detect the efficacy of intranasal dexmedetomidine as a premedication to general anesthesia in pediatric patients with respiratory comorbidities undergoing adenotonsillectomy.

Full description

Respiratory comorbidities are associated with an increased incidence of peri-operative respiratory adverse effects (PRAE).

Upper and lower respiratory infections, as well as asthma, are common in children who are scheduled for adenotonsillectomy. When compared to healthy children, children with respiratory ailments have a three-fold increase in PRAEs.

Enrollment: 70 estimated patients

Sex: All

Ages: 3 to 10 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Children with recent mild URI or asthma.
2. aged from 3 to 10 years
3. ASA Physical Status II,
4. undergoing adenotonsillectomy

Exclusion criteria

1. Parental refusal of participation
2. Evidence of moderate to severe upper respiratory tract infection at time of presentation on the day of surgery
3. Lower respiratory tract infection
4. Congenital heart diseases
5. Known hypersensitivity to specific anesthetic agent
6. Liver or renal disease

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups, including a placebo group

Intranasal

Experimental group

Description:

That will receive intranasal dexmedetomidine (1.5mcg/kg)

Treatment:

Drug: Dexmedetomidine group

control group

Placebo Comparator group

Description:

That will receive the same volume of 2 ml of intranasal normal saline

Treatment:

Other: control group