Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201707002419106 Date of Approval: 11/07/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Emergency agitation in pediatric
Official scientific title Effect of nebulized ketamine vs nebulized lidocaine on postoperative sore throat, and emergency agitation after tonsillectomy in pediatric
Brief summary describing the background and objectives of the trial The occurrence of emergence agitation (EA) in children after sevoflurane anesthesia is common, with a reported incidence up to 80%.[1] EA is characterized by a period of restlessness, agitation, inconsolable crying, disorientation, delusion, hallucination and cognitive changes plus memory impairment. This double blinded randomized prospective study will be conducted to compare the effect of preoperative administration of nebulized ketamine or nebulized lidocaine prior to sevoflurane based anesthesia on the incidence and severity of EA, discharge time and postoperative sore throat in children undergoing adeno-tonsillectomy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Ear, Nose and Throat,emergency agitation and sore throat after tonsellectomy in pediatric,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 30/06/2017
Actual trial start date 31/07/2017
Anticipated date of last follow up 01/05/2018
Actual Last follow-up date 01/05/2018
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 80
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a randomisation table from a statistics book Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group lidocaine group Children in this group will be received 4 mg/kg of nebulized 2% lidocaine with 4.0 ml of saline nebulization Children in this group will for 15 min by face mask immediately bfor surgey. Children in this group will be received 4 mg/kg of nebulized 2% lidocaine with 4.0 ml of saline nebulization for 15 min by face mask immediately bfor surgey. 40 Active-Treatment of Control Group
Experimental Group ketamine group Children in this group will be received nebulized ketamine (2 mg/kg) with 4.0 ml of saline nebulization Children in this group for 15 min by face mask immediately bfor surgey. Children in this group will be received nebulized ketamine (2 mg/kg) with 4.0 ml of saline nebulization for 15 min by face mask immediately bfor surgey. 40 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
80 childern of either sex, ASA I &II, age 3-10 years, scheduled to undergoing undergo adeno-tonsillectomy Seizures background, any type of liver, kidney, lung and heart diseases, catching colds dur¬ing the past four weeks, allergy to lidocaine, and children with severe crying. 3 Year(s) 10 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 21/06/2017 research ethics committee,quality assurance unit
Ethics Committee Address
Street address City Postal code Country
el bahr street, tanta ,elgharbia tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome avoidance of emergency agitation immediate after extubation till 30 minute in PACU
Secondary Outcome avoide devolpement of sore throat immediate after extubation till 30 minute in PACU
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
tanta university hospital el bahr street ,tanta ,elgharbia tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
ear.nose and throat surgery unit ,tanta university hospital el bahr street ,tanta ,elgharbia tanta 31527 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor ear.nose and throat surgery unit ,tanta university hospital el bahr street ,tanta ,elgharbia tanta 31527 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Amany Faheem Abd El Salam Omara. el estad ,tanta, el gharbia tanta 31511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator amany omara amanyfaheem2011@yahoo.com 01008372249 22emar elhoda 1-elestad-elgharbia
City Postal code Country Position/Affiliation
tanta 31511 Egypt
Role Name Email Phone Street address
Public Enquiries amany omara amanyfaheem2011@yahoo.com 01008372249 22emar elhoda 1-elestad-elgharbia
City Postal code Country Position/Affiliation
tanta 31511 Egypt
Role Name Email Phone Street address
Scientific Enquiries motaz abusabaa motazabusabaa@gmail.com +201000029988 manshia albakry_elmahalla elkobra -elgharbia
City Postal code Country Position/Affiliation
elmahalla elkobra Egypt
REPORTING
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