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

Emergence Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04058899
• Other study ID #: Use of dexmedetomidine
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: March 5, 2019
• Est. completion date: September 2019

Study information

• Verified date: August 2019
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Emergence Delirium
• Psychomotor Agitation

Intervention

Drug:
• Dexmedetomidine
sedative and might be analgesic drug
• Nalbuphine
agonist antagonist narcotic

Device:
• infusion pump
infusion pump for titration of fluid containing drug infusion

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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