Dexmedetomidine Versus Nalbuphine in Prevention of Emergence Agitation Following Adenotonsillectomy in Pediatrics
- Conditions
- Emergence Delirium
- Interventions
- Registration Number
- NCT04058899
- Lead Sponsor
- Ain Shams University
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
- Children of (American Society of Anesthesiologist)ASA physical status grade I or II.
- Aged 2-5 years
- Undergoing elective adenotonsillectomy.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description , Dexmedetomidine group(DEX group) infusion pump 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 , Nalbuphine group(NAL group) infusion pump 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. , Dexmedetomidine group(DEX group) Dexmedetomidine 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 , Nalbuphine group(NAL group) Nalbuphine 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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,..
Trial Locations
- Locations (1)
Ain Shams University
🇪🇬Cairo, Egypt