Dyphenhidramine Effect on Prevention of Sevoflurane Induced Post Anesthesia Agitation in Pediatric
1 other identifier
interventional
50
0 countries
N/A
Brief Summary
The purpose of this study is to investigate the effect of diphenhydramine on the prevention of sevoflurane induced emergence delirium/ agitation in pediatrics. The Investigators hypothesis is that it reduce the incidence of sevoflurane induced emergence delirium/ agitation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Apr 2014
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 18, 2015
CompletedFirst Posted
Study publicly available on registry
June 4, 2015
CompletedJune 4, 2015
June 1, 2015
2 months
May 18, 2015
June 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of sevoflurane induced post anesthesia agitation
10 minutes post extubation
Secondary Outcomes (8)
Amount of rescue Ketamine used
1 minute post extubation, at emergence, 15 minute post extubation
Significant adverse events
1 minute post extubation, at emergence, 15 minute post extubation
Mean Pediatric Emergence Agitation and Delirium Score (PAEDS)
1 minute post extubation
Mean Pediatric Emergence Agitation and Delirium Score (PAEDS)
at emergence
Mean Pediatric Emergence Agitation and Delirium Score (PAEDS)
15 minute post extubation
- +3 more secondary outcomes
Study Arms (2)
diphenhydramine
EXPERIMENTALSubject sedated with sevoflurane, and given bilateral extraoral infraorbital block with 0,125% bupivacaine. Subject injected 0,5mg/kg diphenhydramine intravenously, 15 minutes prior to discontinuation of sevoflurane. If subject develop agitation, 0,1 mg/kg ketamine is administered
control
PLACEBO COMPARATORSubject sedated with sevoflurane, and given bilateral extraoral infraorbital block with 0,125% bupivacaine. Subject injected 0,5cc/kg normal saline intravenously, 15 minutes prior to discontinuation of sevoflurane. If subject develop agitation, 0,1 mg/kg ketamine is administered
Interventions
Ketamine 0,1 mg/kg intravenously used as rescue tranquilizer if the subject becomes agitated, repeated dose of 0,05 mg/kg every minute can be given if the agitation does not resolve, maximum ketamine dose for tranquilizer 0,25 mg/kg to prevent deep sedation
Sevoflurane as single sedation agent for general anesthesia in both arm. 8% Sevoflurane in 100% oxygen used as induction agent, and 2% sevoflurane in 50% oxygen used as maintenance agent
Bilateral extraoral infraorbital nerve block with 0,125% Bupivacaine as analgetic for operation and post operation.
Eligibility Criteria
You may qualify if:
- ASA I or 2
- no cardiovascular, respiratory or neurologic congenital anomalies
- no allergic reactions, or any contraindication to drugs used in this trial ever documented
You may not qualify if:
- congenital anomalies recognized/diagnosed during trial procedures
- hemmorhage \> 15% EBV
- shock or other major anesthesia or surgical complications during trial procedures (hipoxia, atelectasis, unintended disconection of ETT or IV line)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universitas Diponegorolead
- Permata Sari Hospital for Plastic Surgerycollaborator
Related Publications (6)
Varughese AM, Rampersad SE, Whitney GM, Flick RP, Anton B, Heitmiller ES. Quality and safety in pediatric anesthesia. Anesth Analg. 2013 Dec;117(6):1408-18. doi: 10.1213/ANE.0b013e318294fb4a.
PMID: 24257392BACKGROUNDCohen IT, Finkel JC, Hannallah RS, Hummer KA, Patel KM. The effect of fentanyl on the emergence characteristics after desflurane or sevoflurane anesthesia in children. Anesth Analg. 2002 May;94(5):1178-81, table of contents. doi: 10.1097/00000539-200205000-00023.
PMID: 11973185BACKGROUNDKoner O, Ture H, Mercan A, Menda F, Sozubir S. Effects of hydroxyzine-midazolam premedication on sevoflurane-induced paediatric emergence agitation: a prospective randomised clinical trial. Eur J Anaesthesiol. 2011 Sep;28(9):640-5. doi: 10.1097/EJA.0b013e328344db1a.
PMID: 21822077BACKGROUNDAbdallah C, Hannallah R. Premedication of the child undergoing surgery. Middle East J Anaesthesiol. 2011 Jun;21(2):165-74. No abstract available.
PMID: 22435268BACKGROUNDAouad MT, Nasr VG. Emergence agitation in children: an update. Curr Opin Anaesthesiol. 2005 Dec;18(6):614-9. doi: 10.1097/01.aco.0000188420.84763.35.
PMID: 16534301BACKGROUNDSimons FE, Simons KJ. Clinical pharmacology of H1-antihistamines. Clin Allergy Immunol. 2002;17:141-78. No abstract available.
PMID: 12113216BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johan Mr Arifin, dr
Universitas Diponegoro
Study Design
- Study Type
- interventional
- Phase
- phase 4
- 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
- Doctor
Study Record Dates
First Submitted
May 18, 2015
First Posted
June 4, 2015
Study Start
April 1, 2014
Primary Completion
June 1, 2014
Study Completion
July 1, 2014
Last Updated
June 4, 2015
Record last verified: 2015-06