Dyphenhidramine Effect on Prevention of Sevoflurane Induced Post Anesthesia Agitation in Pediatric

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 2014

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.

Interventions

  • Drug: Diphenhydramine
    • Intravenous Injection
  • Drug: normal saline
    • Intravenous Injection
  • Drug: Ketamine
    • 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
  • Drug: Sevoflurane
    • 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
  • Drug: Bupivacaine
    • Bilateral extraoral infraorbital nerve block with 0,125% Bupivacaine as analgetic for operation and post operation.

Arms, Groups and Cohorts

  • Experimental: diphenhydramine
    • Subject 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
  • Placebo Comparator: control
    • Subject 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

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of sevoflurane induced post anesthesia agitation
    • Time Frame: 10 minutes post extubation

Secondary Measures

  • Amount of rescue Ketamine used
    • Time Frame: 1 minute post extubation, at emergence, 15 minute post extubation
    • Administration of 0,1 mg/kg ketamine intravenously if the patient gets agitated
  • Significant adverse events
    • Time Frame: 1 minute post extubation, at emergence, 15 minute post extubation
    • Any respiratory or cardiovascular events during observation in recovery room
  • Mean Pediatric Emergence Agitation and Delirium Score (PAEDS)
    • Time Frame: 1 minute post extubation
  • Mean Pediatric Emergence Agitation and Delirium Score (PAEDS)
    • Time Frame: at emergence
  • Mean Pediatric Emergence Agitation and Delirium Score (PAEDS)
    • Time Frame: 15 minute post extubation
  • Incidence of sevoflurane induced post anesthesia agitation
    • Time Frame: 1 minute post extubation
  • Incidence of sevoflurane induced post anesthesia agitation
    • Time Frame: 15 minute post extubation
  • Length of stay in recovery room
    • Time Frame: up to 15 minutes post extubation

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 2 Months

Maximum Age: 24 Months

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Universitas Diponegoro
  • Collaborator
    • Permata Sari Hospital for Plastic Surgery
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ika Cahyo Purnomo, Doctor – Universitas Diponegoro
  • Overall Official(s)
    • Johan Mr Arifin, dr, Study Director, Universitas Diponegoro

References

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.

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.

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.

Abdallah C, Hannallah R. Premedication of the child undergoing surgery. Middle East J Anaesthesiol. 2011 Jun;21(2):165-74. No abstract available.

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.

Simons FE, Simons KJ. Clinical pharmacology of H1-antihistamines. Clin Allergy Immunol. 2002;17:141-78. No abstract available.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.