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

Primary Purpose

Emergence Delirium

Status
Unknown status
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Dexmedetomidine
Nalbuphine
infusion pump
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Emergence Delirium focused on measuring dexmedetomidine, emergence agitation, adenotonsillectomy

Eligibility Criteria

2 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ain Shams University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

, Dexmedetomidine group(DEX group)

Nalbuphine group(NAL group)

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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,..

Full Information

First Posted
July 29, 2019
Last Updated
August 16, 2019
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT04058899
Brief Title
Dexmedetomidine Versus Nalbuphine in Prevention of Emergence Agitation Following Adenotonsillectomy in Pediatrics
Official Title
Dexmedetomidine Versus Nalbuphine in Prevention of Emergence Agitation Following Adenotonsillectomy in Pediatrics
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 5, 2019 (Actual)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergence Delirium
Keywords
dexmedetomidine, emergence agitation, adenotonsillectomy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
, Dexmedetomidine group(DEX group)
Arm Type
Active Comparator
Arm Description
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 ,
Arm Title
Nalbuphine group(NAL group)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
sedative and might be analgesic drug
Intervention Type
Drug
Intervention Name(s)
Nalbuphine
Intervention Description
agonist antagonist narcotic
Intervention Type
Device
Intervention Name(s)
infusion pump
Intervention Description
infusion pump for titration of fluid containing drug infusion
Primary Outcome Measure Information:
Title
postoperative agitation prevention in pediatrics after adenotonsillectomy under sevoflurane anesthesia
Description
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.
Time Frame
stay in postoperative care unit till discharge of patient to ward.Time frame is up to 24 weeks
Secondary Outcome Measure Information:
Title
sedation in early postopertive time during child stay in postanesthesia care unit
Description
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,..
Time Frame
stay in postoperative care unit till discharge of patient to ward.Time frame is up to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Ain Shams University
City
Cairo
ZIP/Postal Code
11566
Country
Egypt

12. IPD Sharing Statement

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

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