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

Sponsor

Ain Shams University (Other)

Overall Status

Unknown status

CT.gov ID

NCT04058899

Collaborator

(none)

120

Enrollment

Location

Arms

5.9

Anticipated Duration (Months)

20.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Emergence Delirium	Drug: Dexmedetomidine Drug: Nalbuphine Device: infusion pump	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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 (Participant, Care Provider)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Mar 5, 2019

Anticipated Primary Completion Date :

Sep 1, 2019

Anticipated Study Completion Date :

Sep 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: , Dexmedetomidine group(DEX group) 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 sedative and might be analgesic drug Device: infusion pump infusion pump for titration of fluid containing drug infusion
Active Comparator: Nalbuphine group(NAL group) 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 agonist antagonist narcotic Device: infusion pump infusion pump for titration of fluid containing drug infusion

Arm

Intervention/Treatment

Active Comparator: , Dexmedetomidine group(DEX group)

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

sedative and might be analgesic drug

Device: infusion pump

infusion pump for titration of fluid containing drug infusion

Active Comparator: Nalbuphine group(NAL group)

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

agonist antagonist narcotic

Device: infusion pump

infusion pump for titration of fluid containing drug infusion

Outcome Measures

Primary Outcome Measures

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

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,..