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.: PACTR202211882566561 Date of Approval: 18/11/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title DETERMINING THE APPROPRIATENESS AND SAFETY OF USING THE INTRANASAL ROUTE FOR SEDATION FOR PAEDIATRIC CT-SCAN AT KORLE-BU TEACHING HOSPITAL, ACCRA, GHANA
Official scientific title FEASIBILITY OF USING INTRANASAL SEDATION FOR PAEDIATRICS CT-SCAN AT THE KORLE-BU TEACHING HOSPITAL, ACCRA, GHANA
Brief summary describing the background and objectives of the trial I. To determine the quality of sedation (time of adequate sedation, sedation failure rate, facilitation of separation from parents, acceptance of intravenous cannulation, and time to discharge from radiological unit) using either intranasal ketamine or intranasal midazolam or a combination of intranasal ketamine and midazolam. II. To determine and compare incidence of adverse outcome (including excessive salivation, nausea, vomiting, bradycardia, tachycardia, wheezing, laryngeal spasm, and apnoea) using either intranasal ketamine or midazolam or a combination of ketamine and midazolam. III. To determine and compare effects on the cardiorespiratory system (i.e. blood pressure [BP], heart rate [HR], oxygen saturation [SpO2], respiratory rate [RR]) using either intranasal ketamine or midazolam or a combination of ketamine and midazolam.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/07/2022
Actual trial start date 01/07/2022
Anticipated date of last follow up 30/11/2022
Actual Last follow-up date 15/12/2022
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
Recruitment status Completed
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 by using procedures such as coin-tossing or dice-rolling 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 Intranasal Sedation with ketamine Patients in one group received 10mg/kg intranasal ketamine which amounted to 0.2ml/kg of the 50mg/ml ketamine parenteral formulation in one dose only. one dose only. sedation lasted 20 minutes to 2 hours The children received the study drugs at approximately twenty (20) minutes before the planned procedure. Upon completion of the study, the identity of the code was revealed as group K- the first intervention group (intranasal ketamine) 10
Experimental Group intranasal Midazolam sedation received 0.2mg/kg intranasal midazolam which amounted to 0.2ml/kg of the 1mg/ml parenteral preparation in a single dose sedation lasted 25minutes to 2 hours The children received the study drugs at approximately twenty (20) minutes before the planned procedure. Upon completion of the study, the identity of the code was revealed as group M- (the second intervention group (intranasal Midazolam) 10
Control Group intranasal combination of ketamine and midazolam sedation the last group received 7.5mg/kg (0.15ml/kg) of ketamine and 0.1mg/kg(0.1ml/kg) of midazolam intranasally in a single dose 20 minutes to 2 hours The children received the study drugs at approximately twenty (20) minutes before the planned procedure. Upon completion of the study, the identity of the code was revealed as group C- the third intervention group (intranasal combination of ketamine and midazolam). All study drugs were prepared to a total volume of 2.5ml for all participants, where half the volume(1.25ml) was placed in each nostril of the child via the LMA mucosal atomization device 10 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion Criteria I. All participants whose parents or guardians, during the period of the study give their signed or thumb-printed informed consent to participate. II. Infants weighing not more than ten (10) kilograms. III. American Society of Anaesthesiology (ASA) I and II physical status (see Appendix 7). Exclusion Criteria I. Children with anomalies of the cardiovascular system. II. Children with known allergy or hypersensitive reaction to midazolam or ketamine. III. Presence of otorhinolaryngeal diseases (e.g., rhinitis, nasal polyposis) IV. Children with upper respiratory tract infection. Infant: 0 Month-23 Month 7 Day(s) 2 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 22/06/2022 Korle Bu Teaching Hospital Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
P. 0. Box 77 Accra 233 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary end-point of the study will be adequate pre-procedural and procedural sedation to complete the scan study 5 minute intervals
Secondary Outcome Secondary endpoints included acceptance of IV cannulation, the ease of separation from parents, haemodynamic effects on blood pressure, heart rate and respiratory rates changes and the incidence of complications. Other secondary outcomes of interest were sedation onset time, recovery time and number of failed sedations. 5 minute intervals
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
radiology department Korle Bu Teaching Hospital P. O. Box KB 77, Korle Bu Accra Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
BEAUTY NAA YARLEY ANNAN P. O. BOX DS 2205, DANSOMAN ACCRA Ghana
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor BEAUTY NAA YARLEY ANNAN P. O. BOX DS2205, DANSOMAN ACCRA Ghana Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator BEAUTY ANNAN beautyannan@gmail.com +233244504657 P. O. BOX DS2205, DANSOMAN
City Postal code Country Position/Affiliation
ACCRA Ghana SENIOR RESIDENT
Role Name Email Phone Street address
Public Enquiries BEAUTY ANNAN beautyannan@gmail.com +233244504657 P. O. BOX DS2205, DANSOMAN
City Postal code Country Position/Affiliation
ACCRA Ghana SENIOR RESIDENT
Role Name Email Phone Street address
Scientific Enquiries BEAUTY ANNAN beautyannan@gmail.com +233244504657 P. O. BOX DS2205, DANSOMAN
City Postal code Country Position/Affiliation
ACCRA Ghana SENIOR RESIDENT
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes ANY INFORMATION ON INDIVIDUAL PARTICIPANT DATA (IPD) WILL BE REQUESTED THROUGH KORLE BU TEACHING HOSPITAL RESEARCH AND DEVELOPMENT DEPARTMENT Informed Consent Form,Statistical Analysis Plan,Study Protocol 1 YEAR CONTROLLED ACCESS
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 07/07/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 07/07/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information