Dyphenhidramine Effect on Prevention of Sevoflurane Induced Post Anesthesia Agitation in Pediatric
Information source: Universitas Diponegoro
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Specified Sedative; Hypnotic
Intervention: Diphenhydramine (Drug); normal saline (Drug); Ketamine (Drug); Sevoflurane (Drug); Bupivacaine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Universitas Diponegoro Official(s) and/or principal investigator(s): Johan Mr Arifin, dr, Study Director, Affiliation: Universitas Diponegoro
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.
Clinical Details
Official title: Dyphenhidramine Effect on Prevention of Sevoflurane Induced Post Anesthesia Agitation in Pediatric
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Incidence of sevoflurane induced post anesthesia agitation
Secondary outcome: Amount of rescue Ketamine usedSignificant adverse events Mean Pediatric Emergence Agitation and Delirium Score (PAEDS) Mean Pediatric Emergence Agitation and Delirium Score (PAEDS) Mean Pediatric Emergence Agitation and Delirium Score (PAEDS) Incidence of sevoflurane induced post anesthesia agitation Incidence of sevoflurane induced post anesthesia agitation Length of stay in recovery room
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
Minimum age: 2 Months.
Maximum age: 24 Months.
Gender(s): Both.
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)
Locations and Contacts
Additional Information
Related publications: 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. Review. 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. Köner O, Türe H, Mercan A, Menda F, Sözübir 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. Abdallah C, Hannallah R. Premedication of the child undergoing surgery. Middle East J Anaesthesiol. 2011 Jun;21(2):165-74. Review. Aouad MT, Nasr VG. Emergence agitation in children: an update. Curr Opin Anaesthesiol. 2005 Dec;18(6):614-9. Simons FE, Simons KJ. Clinical pharmacology of H1-antihistamines. Clin Allergy Immunol. 2002;17:141-78. Review.
Starting date: April 2014
Last updated: June 2, 2015
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