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

NCT04058899 | Unknown Phase 1 DMC

• 1 other identifier: Use of dexmedetomidine
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Emergence Delirium

Keywords

dexmedetomidine; emergence agitation; adenotonsillectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

, Dexmedetomidine group(DEX group)

ACTIVE COMPARATOR

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; Device: infusion pump

Nalbuphine group(NAL group)

ACTIVE COMPARATOR

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; Device: infusion pump

Interventions

Dexmedetomidine DRUG

sedative and might be analgesic drug

, Dexmedetomidine group(DEX group)

Nalbuphine DRUG

agonist antagonist narcotic

Nalbuphine group(NAL group)

infusion pump DEVICE

infusion pump for titration of fluid containing drug infusion

, Dexmedetomidine group(DEX group); Nalbuphine group(NAL group)

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children of (American Society of Anesthesiologist)ASA physical status grade I or II.
• Aged 2-5 years
• Undergoing elective adenotonsillectomy.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 11566, Egypt

Location

MeSH Terms

Conditions

Emergence Delirium

Interventions

Dexmedetomidine; Nalbuphine; Infusion Pumps

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Equipment and Supplies; Artificial Organs; Surgical Equipment

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant proffesor

Model Details: 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.

Study Record Dates

• First Submitted: July 29, 2019
• First Posted: August 16, 2019
• Study Start: March 5, 2019
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: August 20, 2019

Record last verified: 2019-08

Locations

EG (1)