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.: PACTR202208892145772 Date of Approval: 08/08/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effects of oral Dexmedetomidine on incidence of anxiety and emergence delirium in surgical and non-surgical anesthesia in preschool children
Official scientific title Effects of oral Dexmedetomidine on incidence of anxiety and emergence delirium in surgical and non-surgical anesthesia in preschool children
Brief summary describing the background and objectives of the trial Anxiety and emergence delirium are common complication of anesthesia in preschool children. Several reasons had been attributed including younger age, behavioral problems with previous healthcare attendances, longer duration of procedure, having more than five previous hospital admissions and anxious parents. Possible risk factors for emergence delirium includes rapid awakening in an unknown environment, agitation during anesthetic induction, preoperative anxiety, environmental disorders, use of preanesthetic medication, use of inhalational anesthetics, and postoperative pain. Dexmedetomidine would help in reducing both anxiety and emergence delirium in high-risk children. There is paucity of information regarding the effects of Dexmedetomidine on anxiety and emergence delirium in surgical and non-surgical anesthesia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 10/10/2021
Actual trial start date
Anticipated date of last follow up 10/10/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 180
Actual target sample size (number of participants)
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group oral dexmedetomidine drug 4 mcg/kg in apple juice 5 ml 45 minutes before starting anesthesia anesthesia in tonsillectomy with or without adenectomy surgeries 45
Control Group no drug used plain apple juice 5 ml 5 ml plain apple juice 45 minutes before start of anesthesia anesthesia in tonsillectomy with or without adenectomy surgeries 45 Placebo
Experimental Group oral dexmedetomidine drug 4 mcg/kg in apple juice 5 ml 45 minutes before start of anesthesia anesthesia in MRI imaging. 45
Control Group no drug used plain apple juice 5 ml 5 ml plain apple juice 45 minutes before start of anesthesia anesthesia in MRI imaging. 45 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Children of preschool age (2-6 years old) - ASA I- II children - Children undergoing tonsillectomy operation with or without adenectomy. - Expected duration of the procedure is less than 90 minutes - Children undergoing MRI imaging • Cardiovascular, renal, respiratory, hepatic or neurological disease. • Behavioral, mental or developmental abnormality (example: mental retardation, Attention Deficit Hyperactivity Disorder “ADHD”, Autism) • Regular intake of either CNS stimulant or depressive drugs (example: Methylphenidate, amphetamine–dextroamphetamine and diazepam respectively) • Parent’s refusal • Emergency case • Allergy to any of the used drugs Preschool Child: 2 Year-5 Year 2 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 05/10/2021 Research Ethics Committee Faculty of Medicine Ain Shams University
Ethics Committee Address
Street address City Postal code Country
38 Abbasia square near by El Nour mosque Cairo Cairo 1181 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To evaluate the incidence of occurrence of preprocedural anxiety and postprocedural emergence delirium among surgical and non-surgical procedures. Will oral Dexmedetomidine reduce their occurrence? 30 minutes after recovery from anesthesia
Secondary Outcome Effect of oral Dexmedetomidine on severity of emergence delirium and pain management Effect of oral Dexmedetomidine on severity of emergence delirium and pain.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of medicine Ain shams University hospitals Abbasia - Nearby Elnour mosque- cairo Cairo 1181 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self funded Faculty of medicine Ain Shams University Cairo Cairo 1181 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of medicine Ain Shams University 38 Abbasia nearby ELNour mosque Cairo 1181 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Sharaf ahmed.i.ali@med.asu.edu.eg +201228802912 6 Dr Hassan Ibrahim Hassan St. Off Makram Ebeid St. Nasrcity
City Postal code Country Position/Affiliation
Cairo 11371 Egypt Assistant Lecturer in Department of Anesthesia Faculty of Medicine Ain Shams University
Role Name Email Phone Street address
Public Enquiries Hany ElZahaby hanyzahaby@hotmail.com +201227463000 Faculty of medicine Ain Shams University
City Postal code Country Position/Affiliation
Cairo Egypt Professor at Anesthesia Department Faculty of Medicine Ain Shams University
Role Name Email Phone Street address
Scientific Enquiries Mohamed Awad Mohsen.Mohamed1983@gmail.com +201204227780 Fifth Settlement New Cairo
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer at Anesthesia Department Faculty of Medicine Ain Shams University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual data collected during the trial after deidentification Study Protocol following publication any purpose
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information