Emergence Delirium
Conditions
Keywords
dexmedetomidine, emergence agitation, adenotonsillectomy
Brief summary
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
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.
Interventions
DRUGDexmedetomidine
sedative and might be analgesic drug
DRUGNalbuphine
agonist antagonist narcotic
DEVICEinfusion pump
infusion pump for titration of fluid containing drug infusion
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
2 Years to 5 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postoperative agitation prevention in pediatrics after adenotonsillectomy under sevoflurane anesthesia | stay in postoperative care unit till discharge of patient to ward.Time frame is up to 24 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| sedation in early postopertive time during child stay in postanesthesia care unit | stay in postoperative care unit till discharge of patient to ward.Time frame is up to 24 weeks | 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,.. |
Countries
Egypt
Outcome results
None listed