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Intravenous Dexmedetomidine for Emergence Delirium in Pediatric Patient

Primary Purpose

Emergence Delirium, Dexmeditomidine

Status
Recruiting
Phase
Phase 4
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Dexmedetomidine Hydrochloride
normal saline
Sponsored by
Security Forces Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Emergence Delirium focused on measuring emergence delirium, dexmeditomidine, pediatric patients

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients aged between 2 and 12 years, scheduled to undergo general anesthesia for a surgery with an ASA score of 1 to 3 will be included in the study. Exclusion Criteria: Parents who refused enrollment or later requested removal for the study, those who are unable to give informed consent and patients with known allergy to dexmedetomidine, psychiatric disorders or use of psychiatric medications will not be included in the study

Sites / Locations

  • Security Forces HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dexmedetomidine group

Control group

Arm Description

These patients will receive 0.2 mcg/kg dexmedetomidine intravenously 30 minutes before end

These patients will receive normal saline intravenously 30 minutes before end

Outcomes

Primary Outcome Measures

Emergence delirium
Emergence delirium will be measured using PAED score

Secondary Outcome Measures

Pain score
VAS pain score
Opioid consumption
Morphine equivalent opioid consumption
Side effects
Side effects including PONV, drowsiness

Full Information

First Posted
February 21, 2023
Last Updated
April 13, 2023
Sponsor
Security Forces Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05813106
Brief Title
Intravenous Dexmedetomidine for Emergence Delirium in Pediatric Patient
Official Title
Effect of Fixed Dose Intravenous Dexmedetomidine on Emergence Delirium After General Anesthesia for a Surgery in Pediatric Patient
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Security Forces Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Various pharmacological interventions in peri-operative period have been used in literature to prevent ED which include use of propofol, fentanyl, ketamine, clonidine, midazolam and dexmedetomidine etc (5). Dexmedetomidine is a potent highly selective alpha-2 agonist. Its effect on the receptors in brain results in sedation resembling non-REM sleep with minimal respiratory depression (6). It has been used as continuous infusion or as fixed dose in the range between 0.15 mcg/kg to 2 mcg/kg to prevent ED in children (7, 8, 9). Higher doses result in better prevention of ED at the expense of more hemodynamic disturbances and longer PACU stay (9) while lower doses were not as effective (7). The aim of this study was to investigate the role of fixed dose of 0.2 mcg/kg dexmedetomidine in prevention of emergence delirium in pediatric patients undergoing general anesthesia.
Detailed Description
Emergence delirium (ED) is an altered state of consciousness that usually occurs within 45 minutes after cessation of anesthesia. It typically presents as disorientation, averted eyes or staring, psychomotor agitation and non-purposeful, resistive movements like pulling, kicking or flailing (1, 2). ED can result in potential risk of bodily harm to patient or healthcare staffs, prolonged PACU (post-anesthesia care unit) stay and postoperative maladaptive changes including temper tantrums, attention seeking, sleep alterations and bed wetting in children (2). Risk factors for ED include preoperative anxiety and confusion, psychological immaturity and use of various medications peri-operatively (2, 3). The incidence of ED varies by age of patient, anesthesia technique, type of surgeries, pain and also by choice of tool to diagnose ED. It occurs two to three more commonly in children as compared to adults. Scientific literature suggest the incidence of ED in the range between 20 -80 % in pediatric anesthesia practice (4). Various pharmacological interventions in peri-operative period have been used in literature to prevent ED which include use of propofol, fentanyl, ketamine, clonidine, midazolam and dexmedetomidine etc (5). Dexmedetomidine is a potent highly selective alpha-2 agonist. Its effect on the receptors in brain results in sedation resembling non-REM sleep with minimal respiratory depression (6). It has been used as continuous infusion or as fixed dose in the range between 0.15 mcg/kg to 2 mcg/kg to prevent ED in children (7, 8, 9). Higher doses result in better prevention of ED at the expense of more hemodynamic disturbances and longer PACU stay (9) while lower doses were not as effective (7). The aim of this study was to investigate the role of fixed dose of 0.2 mcg/kg dexmedetomidine in prevention of emergence delirium in pediatric patients undergoing general anesthesia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergence Delirium, Dexmeditomidine
Keywords
emergence delirium, dexmeditomidine, pediatric patients

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
2 groups One group will receive IV dexmedetomidine Other control group receive normal saline
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine group
Arm Type
Experimental
Arm Description
These patients will receive 0.2 mcg/kg dexmedetomidine intravenously 30 minutes before end
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
These patients will receive normal saline intravenously 30 minutes before end
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine Hydrochloride
Other Intervention Name(s)
Precedex
Intervention Description
Intravenous dexmedetomidine 0.2 mcg/kg
Intervention Type
Drug
Intervention Name(s)
normal saline
Intervention Description
normal saline
Primary Outcome Measure Information:
Title
Emergence delirium
Description
Emergence delirium will be measured using PAED score
Time Frame
up to 120 minutes
Secondary Outcome Measure Information:
Title
Pain score
Description
VAS pain score
Time Frame
every 15 minutes upto discharge from PACU maximum 120 minutes
Title
Opioid consumption
Description
Morphine equivalent opioid consumption
Time Frame
upto discharge from PACU maximum 120 minutes
Title
Side effects
Description
Side effects including PONV, drowsiness
Time Frame
PACU stay maximum 120 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged between 2 and 12 years, scheduled to undergo general anesthesia for a surgery with an ASA score of 1 to 3 will be included in the study. Exclusion Criteria: Parents who refused enrollment or later requested removal for the study, those who are unable to give informed consent and patients with known allergy to dexmedetomidine, psychiatric disorders or use of psychiatric medications will not be included in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anwar ul Huda, FRCA
Phone
00966118024331
Email
hudaanwar90@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anwar ul Huda, FRCA
Organizational Affiliation
Security Forces Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Security Forces Hospital
City
Riyadh
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anwar ul huda, FRCA
Phone
0502654719

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We can share IPD on request
IPD Sharing Time Frame
After publication for 6 months
IPD Sharing Access Criteria
Direct communication to PI

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Intravenous Dexmedetomidine for Emergence Delirium in Pediatric Patient

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