Dexmedetomidine Versus Nalbuphine in Prevention of Emergence Agitation Following Adenotonsillectomy in Pediatrics

Study Overview
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Brief Summary
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The aim of the present study is to compare the effect of IV infusion 0.5 µg/kg dexmedetomidine and IV 0.1 mg/kg nalbuphine in preschool children for prevention of emergence agitation after adenotonsillectomy under sevoflurane anesthesia.

Detailed Description
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Consent will be obtained from legal guardian of children,patients will be randomized according to computer randomization to one of two groups, dexmedetomidine group (DEX)group who will receive 0.5 µg/kg dexmedetomidine diluted in 50 ml of normal saline 0.9% to be given by IV infusion over 10 minutes after induction of anesthesia then 5ml of 0.9% normal saline IV ,nalbuphine group (NAL)group will receive IV infusion of 50 ml of 0,9%normal saline by IV infusion over 10 minutes then 0.1mg/kg nalbuphine diluted in 5ml of 0.9%normal saline IV after induction of anesthesia.

Official Title
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Dexmedetomidine Versus Nalbuphine in Prevention of Emergence Agitation Following Adenotonsillectomy in Pediatrics

Conditions
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Emergence Delirium

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Nalbuphine
* Device: infusion pump


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children of (American Society of Anesthesiologist)ASA physical status grade I or II. Aged 2-5 years Undergoing elective adenotonsillectomy. Exclusion Criteria: History of hypersensitivity to the studied drug. Refusal of the legal guardian to participate in the study. Severely agitated child at induction of anesthesia Occurrence of postoperative bleeding at(Post Anesthesia Care Unit) PACU

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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
Interventional Model Description: Patients will be divided into 2 groups ,dexmedetomidine group (DEX)group who will receive 0.5 µg/kg dexmedetomidine diluted in 50 ml of normal saline 0.9% to be given by IV infusion over 10 minutes after induction of anesthesia then 5ml of 0.9% normal saline IV ,nalbuphine group (NAL)group will receive IV infusion of 50 ml of 0,9%normal saline by IV infusion over 10 minutes then 0.1mg/kg nalbuphine diluted in 5ml of 0.9%normal saline IV after induction of anesthesia.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: , Dexmedetomidine group(DEX group)<br>dexmedetomidine group (DEX)group who will receive 0.5 µg/kg dexmedetomidine diluted in 50 ml of normal saline 0.9% to be given by IV infusion over 10 minutes after induction of anesthesa then 5ml of 0.9% normal saline IV , | Drug: Dexmedetomidine<br>* sedative and might be analgesic drug<br>Device: infusion pump<br>* infusion pump for titration of fluid containing drug infusion<br>|
| Active Comparator: Nalbuphine group(NAL group)<br>nalbuphine group (NAL)group will receive IV infusion of 50 ml of 0,9%normal saline by IV infusion over 10 minutes then 0.1mg/kg nalbuphine diluted in 5ml of 0.9%normal saline IV after induction of anesthesia. | Drug: Nalbuphine<br>* agonist antagonist narcotic<br>Device: infusion pump<br>* infusion pump for titration of fluid containing drug infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative agitation prevention in pediatrics after adenotonsillectomy under sevoflurane anesthesia | during stay in postoperative care unit using pediatric anesthesia emergence delirium score (PAED) as score equal or more than 16/20 is considered presence of agitation. during stay in postanesthesia care unit,score will be documented every 10 minutes by recovery staff. | stay in postoperative care unit till discharge of patient to ward.Time frame is up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sedation in early postopertive time during child stay in postanesthesia care unit | stay in postoperative care unit using Ramsay sedation score evey 10 minutes till discharge to ward,assessed by recovery staff..Presence of score 4/6 or more means that child is sedated,and needs more time in recovery,.. | stay in postoperative care unit till discharge of patient to ward.Time frame is up to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dexmedetomidine, emergence agitation, adenotonsillectomy