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

NCT ID: NCT04058899

Last Updated: 2019-08-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-05
• Study Completion Date: 2019-09-30

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.

Conditions

Emergence Delirium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

, 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 ,

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type: DRUG

sedative and might be analgesic drug

infusion pump

Intervention Type: DEVICE

infusion pump for titration of fluid containing drug infusion

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.

Group Type: ACTIVE_COMPARATOR

Nalbuphine

Intervention Type: DRUG

agonist antagonist narcotic

infusion pump

Intervention Type: DEVICE

infusion pump for titration of fluid containing drug infusion

Interventions

Dexmedetomidine

sedative and might be analgesic drug

Intervention Type: DRUG

Nalbuphine

agonist antagonist narcotic

Intervention Type: DRUG

infusion pump

infusion pump for titration of fluid containing drug infusion

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Ashraf Elsayed Elagamy

Assisstant proffesor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ain Shams University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

Use of dexmedetomidine

Identifier Type: -

Identifier Source: org_study_id