Transbucal Dexmedetomidine for Prevention of Sevoflurane Emergence Agitation in Pre-school Children
1 other identifier
interventional
90
1 country
1
Brief Summary
The aim of this study is to evaluate the efficacy of transbucal dexmedetomidine given in preschool children undergoing tonsillectomy operations in the prevention sevoflurane agitation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2016
CompletedFirst Posted
Study publicly available on registry
March 28, 2016
CompletedStudy Start
First participant enrolled
May 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2018
CompletedJuly 14, 2020
July 1, 2020
2.4 years
March 17, 2016
July 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The agitation score up to 1hour postoperative.
Agitation intensity will be assessed postoperatively by using agitation score 0= child is asleep. awake/calm =1. irritable/ consolable cry =2. inconsolable cry =3.the child is agitating and thrashing and restlessness Emergence delirium ≥ 3 agitation score will be performed in the following time points; at 5 min postoperative,10 min, 15, 30, 45, 60 min.
first postoperative hour
Secondary Outcomes (1)
Pain score assessed using the objective pain scale.
up to 1hour postoperative hour
Study Arms (3)
DEX I
ACTIVE COMPARATORactive comparator receive 0.5µg/kg dexmedetomidine orally half an hour before operation
Saline Control
PLACEBO COMPARATOR2ml oral 0.9%saline half an hour before operation
DEX II
ACTIVE COMPARATORactive comparator receive,1µg/kg dexmedetomidine orally half an hour before operation
Interventions
2ml 0.9% saline administered orally half an hour before induction of anesthesia
Eligibility Criteria
You may qualify if:
- ASA physical status I-II patients
- aged 2-6 years
- patient scheduled for elective tonsillectomy due to recurrent
- chronic tonsillitis
You may not qualify if:
- patients with known hypersensitivity to medication drugs
- coagulation disorders
- thrombocytopenia
- significant cardiac
- renal
- pulmonary
- hepatic disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assiut university hospitals
Asyut, Assiut,Egypt,71571, Egypt
Related Publications (1)
Abdel-Ghaffar HS, Abdel-Wahab AH, Roushdy MM. [Oral trans-mucosal dexmedetomidine for controlling of emergence agitation in children undergoing tonsillectomy: a randomized controlled trial]. Braz J Anesthesiol. 2019 Sep-Oct;69(5):469-476. doi: 10.1016/j.bjan.2019.06.012. Epub 2019 Oct 28.
PMID: 31672419DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Halla s Abdel-Ghaffar Abdel-Ghaffar, MD
assisstant professor in anesthesia and intensive care departement,faculty of medicine,Assiut university,Egypt
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
March 17, 2016
First Posted
March 28, 2016
Study Start
May 1, 2016
Primary Completion
October 1, 2018
Study Completion
November 1, 2018
Last Updated
July 14, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share