Clinical trial NCT02463929: Dyphenhidramine Effect on Prevention of Sevoflurane Induced Post Anesthesia Agitation in Pediatric
Official title: Dyphenhidramine Effect on Prevention of Sevoflurane Induced Post Anesthesia Agitation in Pediatric
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Specified Sedative
Hypnotic
Keywords: Diphenhydramine
emergence agitation
pediatric anesthesia
PAEDS
Withdrawal
Lead sponsor: Universitas Diponegoro
Sponsor class: OTHER
Collaborators: name: Permata Sari Hospital for Plastic Surgery
First posted: 2015-06-04
Enrollment: 50
Sex: ALL
Minimum age (years): 2
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: This is an experimental clinical trial in double-blinded randomized controlled design on 50 children aged 10 months to 21 months who underwent general anesthesia with sevoflurane for labioplasty surgery. Fifteen minutes before inhalation anesthetics were discontinued, the subjects were randomly given a placebo or a single dose of diphenhydramine 0, 5 mg / kg intravenously. Subjects were extubated and observed in the recovered space conscious for any agitation or emergence delirium and feasability to return to the ward. Agitation or emergence delirium was assessed by the Pediatric Emergence Agitation and Delirium Score (PAEDS) whereas feasability to return to the ward scored with the Steward score. When PAEDS\> 10 patients were assessed to be agitated or having emergence delirium and administeres rescue tranquilizer ketamine 0.1 mg / kg. Total rescue tranquilizers and clinically significant adverse effects of drugs also recorded.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Incidence of sevoflurane induced post anesthesia agitation
timeFrame: 10 minutes post extubation
Secondary outcomes:
measure: Amount of rescue Ketamine used
timeFrame: 1 minute post extubation, at emergence, 15 minute post extubation
measure: Significant adverse events
timeFrame: 1 minute post extubation, at emergence, 15 minute post extubation
measure: Mean Pediatric Emergence Agitation and Delirium Score (PAEDS)
timeFrame: 1 minute post extubation
measure: Mean Pediatric Emergence Agitation and Delirium Score (PAEDS)
timeFrame: at emergence
measure: Mean Pediatric Emergence Agitation and Delirium Score (PAEDS)
timeFrame: 15 minute post extubation
measure: Incidence of sevoflurane induced post anesthesia agitation
timeFrame: 1 minute post extubation
measure: Incidence of sevoflurane induced post anesthesia agitation
timeFrame: 15 minute post extubation
measure: Length of stay in recovery room
timeFrame: up to 15 minutes post extubation
Other outcomes:
Locations:
Study officials:
affiliation: Universitas Diponegoro
name: Johan Mr Arifin, dr
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Cohen 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.
citation: Koner 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.
citation: Abdallah C, Hannallah R. Premedication of the child undergoing surgery. Middle East J Anaesthesiol. 2011 Jun;21(2):165-74. No abstract available.
citation: Aouad 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.
citation: Simons FE, Simons KJ. Clinical pharmacology of H1-antihistamines. Clin Allergy Immunol. 2002;17:141-78. No abstract available.