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.: PACTR201804003286743 Date of Approval: 03/04/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Proper premedication may alleviate or prevent the development of emergence agitation
Official scientific title Emergence Agitation after Pediatric Sevoflurane Anesthesia: A Placebo-controlled study for evaluation of prophylactic effect of oral premedication
Brief summary describing the background and objectives of the trial Evaluation of the ameliorative effect of premedication using oral midazolam, clonidine or gabapentine on the incidence of emergence agitation during recovery from sevoflurane anesthesia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Evaluation of the ameliorative effect of premedication using oral midazolam, clonidine or gabapentine on the incidence of emergence agitation during recovery from sevoflurane anesthesia.,Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 03/04/2018
Actual trial start date 03/04/2018
Anticipated date of last follow up 03/10/2018
Actual Last follow-up date 03/10/2018
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 200
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 radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group I 0.25 mg/kg receive oral midazolam 50
Experimental Group group II 4 microgram/kg receive oral clonidine 50
Experimental Group group III 10mg/kg receive oral gabapentin 50
Control Group Group IV recieve a placebo oral medication 50 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
children scheduled for elective outpatient pediatric surgeries as adeniodectomy,tonsillectomy, cleft clip,cleft palate and squint allergy to any medication used,patients with upper respiratory infection and patients with ASA III and IV 3 Year(s) 12 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 01/04/2018 aswan university
Ethics Committee Address
Street address City Postal code Country
el seel street aswan 35127 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the incidence of emergence agitation as evaluated by using the pediatric anesthesia emergence delirium scale and the four-point agitation scale. after the end of the procedure
Secondary Outcome time to emergence, defined as the time from sevoflurane discontinuation to the time to extubation. after the end of the procedure
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of medicine Aswan umiversity el seel street aswan 35127 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
amir abozikary el sayed el seel street aswan 35127 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor sherif kamal arafa el bahr street tanta 35127 Egypt Funding Agency
Secondary Sponsor amir abozikary el sayed el seel street aswan 35127 Egypt Funding Agency
COLLABORATORS
Name Street address City Postal code Country
sherif kamal arafa el bahr street tanta 35127 Egypt
amir abozikary el sayed el seel street aswan 35127 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator sherif arafa sherifarafa1020@gmail.com 01005714014 el bahr street
City Postal code Country Position/Affiliation
tanta 35127 Egypt lecturer of anesthesia , icu .aswan university
Role Name Email Phone Street address
Public Enquiries sherif arafa sherifarafa1020@gmail.com 01005714014 el bahr street
City Postal code Country Position/Affiliation
tanta 35127 Egypt lecturer of anesthesia , icu .aswan university
Role Name Email Phone Street address
Scientific Enquiries sherif arafa sherifarafa1020@gmail.com 01005714014 el bahr street
City Postal code Country Position/Affiliation
tanta 35127 Egypt lecturer of anesthesia , icu .aswan university
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information