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.: PACTR201403000762218 Date of Approval: 06/02/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title sedation in children with hematology cancer
Official scientific title The Incidence and Nature of Adverse Events during Paediatric Sedation and analgesia: A randomized crossover controlled trial
Brief summary describing the background and objectives of the trial This is a prospective, open-label, cross over randomized trial which will involve 60 ASA I-II children aged 1-15 years undergoing procedural sedation and analgesia for haematological malignancy. The study will be in two phases, at the end of the first phase the patients will switch to the other agent. In phase one of the study, children will be randomly selected into two groups, group PK will receive ketofol (1:1 mixture of propofol and ketamine), and group MK will receive a mixture of midazolam (0.05mg/kg) and ketamine (1.5mg/kg). Each phase will consist of two sessions of sedation procedure, at three weeks interval per patient. In phase two of the study, the patients in group PK that received ketofol will now switch to midazolam/ketamine mixture and vice versa for those in group MK. The second phase will consist of a second two sessions of sedation procedure, at three weeks interval. Objectives: To determine the incidences and nature of adverse effects of ketofol versus midazolam/ketamine mixtures in children for procedural sedation with haematological malignancy
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,cancer,Paediatrics,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 06/01/2014
Actual trial start date 10/02/2014
Anticipated date of last follow up 12/12/2014
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
ADM/DCST/HREC/1524 HUMAN RESEARCH ETHIC COMMITTEE OF LAGOS UNIVERSITY TEACHING HOSPITAL
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
Crossover: all participants receive all interventions in different sequence during study Randomised Patients will be randomly divided into 2 groups of 30 through the use of computer generated random numbers open labelled Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group ketofol (1:1 mixture of propofol and ketamine) 0.5mg/kg of propofol and 0.5mg/kg of ketamine during sedation ketofol will be prepared as a 1:1 mixture of 10 mg¿ml propofol and 10 mg¿ml ketamine., the children that will receive ketofol will be administered 0.5mg/kg of propofol and ketamine 30 Active-Treatment of Control Group
Experimental Group MK group a mixture of midazolam(0.05mg/kg) and ketamine (1.5mg/kg) during sedation a mixture of midazolam(0.05mg/kg) and ketamine (1.5mg/kg) 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA I-II children aged 1-15 years undergoing procedural sedation and analgesia for haematological malignancy All consecutive children with haematological cancer undergoing bone marrow aspiration/biopsy and lumbar puncture (LP) for chemotherapy in the paediatric oncology ward prior sensitization or allergic reaction to propofol, ketamine, soy or egg products presences of hypotension, head injury, increased intracranial increased intraocular pressure use of drugs known to interact with any of the study agent patients who have been involved in another study in the last 30 days. Patients with heart, lung or neurological disease, and central nervous system disorders symptomatic thrombocytopenia, age less than 1 year or over 15 years ASA IV-V patients 1 Year(s) 15 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 12/12/2013 HUMAN RESEARCH ETHIC COMMITTE OF LAGOS UNVERSITY TEACHING HOSPITAL
Ethics Committee Address
Street address City Postal code Country
ROOM 109, ADMINISTRATIVE BLOCK, LAGOS UNIVERSITY TEACHING HOSPITAL lagos +2341 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. A change less than or greater than 20% change in Heart Rate 2. A change less than or greater than 20% in Respiratory Rate 3. Systolic blood pressure greater than the fifth percentile of normal for age 4. Systolic blood pressure less than the fifth percentile of normal for age 5. Movement during sedation during sedation
Secondary Outcome 1. To determine if spontaneous ventilation continues following administration of the anaesthetic agents for sedation. 2. Pain (Yes/No), the participant will be monitored from the end of the procedure until sedation recovery during and after the procedure
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
LAGOS UNIVERSITY TEACHING HOSPITAL P.M.B 12003, SURULERE, LAGOS LAGOS +2341 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
LANTETE AUTO NIG LTD 2ND AVENUE, 201 RD 'A' CLOSE FESTAC LAGOS +2341 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor ADEKOLA LATEEF 2ND AVENUE, 201 RD 'A' CLOSE FESTAC LAGOS +2341 Nigeria Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
TEMIYE DEPT OF PAEDIARICS, LAGOS UNIVERSITY TEACHING HOSPITAL, LAGOS LAGOS +2341 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator oyebola Adekola oyebolaadekola@yahoo.com +2348033242924 1 LUTH Road, Idi-araba, Surulere
City Postal code Country Position/Affiliation
lagos +2341 Nigeria Consultant Anaesthetist/Lagos University Teaching Hospital
Role Name Email Phone Street address
Public Enquiries E Temiye emtemiye@unikag.edu.ng +2348023123902 1 LUTH Road, Idi-araba, Surulere
City Postal code Country Position/Affiliation
lagos +2341 Nigeria Professor of Paediatric Oncology/ Lagos University Teaching Hospital
Role Name Email Phone Street address
Scientific Enquiries Ronke Desalu ronkedesalu@yahoo.com +2348033042730 1 LUTH Road, Idi-araba, Surulere
City Postal code Country Position/Affiliation
lagos +2341 Nigeria Associate Prof. Of Anaesthesia/Lagos University Teaching Hospital
REPORTING
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