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

Ain Shams University120 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

120

Conditions

Emergence Delirium

Interventions

DexmedetomidineDRUG

sedative and might be analgesic drug

NalbuphineDRUG

agonist antagonist narcotic

infusion pumpDEVICE

infusion pump for titration of fluid containing drug infusion

Eligibility

Sex: ALLMin age: 2 YearsMax age: 5 Years

Medical Language ↔ Plain English

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

Locations (1)

Ain Shams University

Cairo, Egypt

Outcomes

Primary Outcomes

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.

Time frame: stay in postoperative care unit till discharge of patient to ward.Time frame is up to 24 weeks

Secondary Outcomes

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,..

Time frame: stay in postoperative care unit till discharge of patient to ward.Time frame is up to 24 weeks

Data from ClinicalTrials.gov

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