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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Intranasal Dexmedetomidine Premedication in Children Undergoing Adenotonsillectomy Suffering From Recent Mild Upper Respiratory Tract Infection

Conditions
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Dexmedetomidine, Adenotonsillectomy, Respiratory Tract Infections

Intervention / Treatment
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* Drug: Dexmedetomidine group
* Other: control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children with recent mild URI or asthma. aged from 3 to 10 years ASA Physical Status II, undergoing adenotonsillectomy Exclusion Criteria: Parental refusal of participation Evidence of moderate to severe upper respiratory tract infection at time of presentation on the day of surgery Lower respiratory tract infection Congenital heart diseases Known hypersensitivity to specific anesthetic agent Liver or renal disease

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intranasal<br>That will receive intranasal dexmedetomidine (1.5mcg/kg) | Drug: Dexmedetomidine group<br>* That will receive intranasal dexmedetomidine (1.5mcg/kg)<br>* Other names: Precedex;|
| Placebo Comparator: control group<br>That will receive the same volume of 2 ml of intranasal normal saline | Other: control group<br>* That will receive the same volume of 2 ml of intranasal normal saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of peri-operative respiratory adverse effects (PRAE). | All PRAE and the time of occurrence (induction, maintenance or emergence) will be recorded. | From induction to emergence from general anesthesia. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sedating effects of this drug. | The sedating effects will be measure using Ramsay sedation scale from 1 to 6 as 1 meaning anxious and agitated, restless, or both. and 6 meaning Unresponsive. | 15 and 30 min after sedation | 
| Ease of parental separation. | Evaluated using a four-point scale. from 1 to 4 as 1 meaning excellent and 4 for poor | 15 and 30 min after sedation | 
| Face mask acceptance. | Evaluated using a four-point scale. from 1 to 4 as 1 meaning excellent and 4 for poor | 15 and 30 min after sedation | 
| Hemodynamic stability | hypertension, tachycardia, bradycardia | 15 and 30 min after sedation |