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.: PACTR201610001691412 Date of Approval: 23/06/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title COMPARISON BETWEEN NEBULIZED DEXMEDETOMIDINE, KETAMINE AND A MIXTURE OF BOTH AS PREMEDICATION IN PEDIATRICS UNDERGOING TONSILLECTOMY SURGERY
Official scientific title COMPARISON BETWEEN NEBULIZED DEXMEDETOMIDINE, KETAMINE AND A MIXTURE OF BOTH AS PREMEDICATION IN PEDIATRICS UNDERGOING TONSILLECTOMY SURGERY
Brief summary describing the background and objectives of the trial To compare between nebulized dexmedetomidine, nebulized ketamine and a mixture of both as a premedication in children (3-6) years old undergoing tonsillectomy, as regards their sedating effect as the primary end point, , ease of parentral separation and face mask acceptance, analgesia, hemodynamic stability and sedation at emergence as the seconadry end points.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Paediatrics,Preoperative anxiety, Tonsillectomy,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 24/06/2016
Actual trial start date 25/06/2016
Anticipated date of last follow up 31/08/2016
Actual Last follow-up date 31/08/2016
Anticipated target sample size (number of participants) 75
Actual target sample size (number of participants) 75
Recruitment status 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 Closed envelopes Simple randomisation using by using procedures such as coin-tossing or dice-rolling 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 Nebulized medications Dexmedetomidine. Preoperative 30min Nebulized medications 25
Experimental Group Nebulized medications Dexmedetomidine/Ketamine. 30 sedation. 25
Experimental Group Nebulized medications Ketamine. 30 min sedation. 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The study will be carried out in Alexandria University Hospitals on patients scheduled for tonsillectomy surgery. The sample size is approved to be sufficient by the department of statistcs, High Institute of Public Health, University of Alexandria. ¿ Chest infection or respiratory disease. ¿ Cardiac disease. ¿ Mental retardation or physical disability. ¿ Children treated with sedatives or anticonvulsants. ¿ Parents refuse to allow them to participate. 3 Year(s) 6 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 24/01/2016 Alexandria Ethics commettee
Ethics Committee Address
Street address City Postal code Country
Shalalat, Khartoum Square Alexandria 21111 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Sedation Will be recorded 30 minutes after sedation.
Secondary Outcome Ease of parental separation, face mask acceptance. When leaving the parents
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alexandria Univerity Hospitals Shalalat, KhaRTOUM SQUARE Alexandria 21111 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Alexandria Univerity Hospitals Shalalat, Khartoum Square Alexandria 21111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Alexandria Univerity Hospitals Shalalat, Khartoum Square Alexandria 21111 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Nourhan Elhelw Shalalat, Khartoum Square Alexandria 21111 Egypt
Nader Elgamal Shalalat, Khartoum Square Alexandria 21111 Egypt
Ramadan Ammar Shalalat, Khartoum Square Alexandria 21111 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohammad Hazem Ahmad Sabry mohammad_hazem@yahoo.com +203-487-0509 20 Amin Fekry St.
City Postal code Country Position/Affiliation
Ramleh Square 21111 Egypt Alexandria Faculty of Medicine
Role Name Email Phone Street address
Public Enquiries Mohammad Hazem Ahmad Sabry mohammad_hazem@yahoo.com +20106-2718827 20 Amin Fekry St. Ramleh Square.
City Postal code Country Position/Affiliation
Alexandria 21111 Egypt Lecturer
Role Name Email Phone Street address
Scientific Enquiries Mohammad Hazem Ahmad Sabry mohammad_hazem@yahoo.com +20106-2718827 20 Amin Fekry St. Ramleh Square.
City Postal code Country Position/Affiliation
Alexandria 21111 Egypt Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
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