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.: PACTR201401000670381 Date of Approval: 07/10/2013
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Influence of Lignocaine on the Tolerability and Pharmacokinetics of Intramuscular Amikacin: A Double-Blind Randomised Cross-Over Trial
Official scientific title Influence of Lignocaine on the Tolerability and Pharmacokinetics of Intramuscular Amikacin: A Double-Blind Randomised Cross-Over Trial
Brief summary describing the background and objectives of the trial There is currently no consistent policy on the use of local anaesthetic agents with the intramuscular administration of injectable agents in either adults or children due to a lack of evidence. We aim to establish the effect of lignocaine co-administration on the tolerability of intramuscular injections as well as the impact on the bioavailability of injectable agents used to treat MDR- and XDR-TB and the occurrence of any adverse events.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Tuberculosis
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/07/2013
Actual trial start date 16/10/2013
Anticipated date of last follow up 31/07/2014
Actual Last follow-up date
Anticipated target sample size (number of participants) 12
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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomisation using a randomisation table created by a computer software program using restricted blocked randomisation 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 lignocaine 0.2 - 0.5ml of 2% stat with injection Two separate PK assessments will be performed. One PK will be performed with amikacin and lignocaine administered together as a single injection and the other PK will be performed with amikacin without lignocaine. The order of the injections will be determined by randomisation. 12
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. children aged between eight and seventeen years of age who are routinely treated with intramuscular amikacin as part of their drug-resistant TB regimen 2. children receiving intramuscular amikacin for at least fourteen days but less than eight weeks at enrolment 1. Informed consent and/or assent not obtained 2. Acute illness 3. Significant neurological impairment 4. Haemoglobin of less than 8g/dl 5. Weight less than 10kg 8 Year(s) 17 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 19/09/2012 Stellenbosch University Health Research Ethics Committee 1
Ethics Committee Address
Street address City Postal code Country
Francie van Zyl Drive, Parow Cape Town 7500 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome Local or systemic adverse effects occurring when lignocaine is administered together with amikacin in an intramuscular injection At each pharmacokinetic study, the participant will be assessed for possible adverse events
Primary Outcome The change in pain intensity achieved when lignocaine is co-administered with intramuscular injection of amikacin, as measured by the FACES pain scale Pain will be assessed after each injection. At the end of the study the difference in pain will be assessed.
Secondary Outcome The bioavailability of amikacin when co-administered with lignocaine as an intramuscular injection Evaluated at end of study after both pharmacokinetic assessments are performed.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Desmond Tutu TB Cetnre Faculty of Medicine and Health Sciences, Francie van Zyl Drive, Parow Cape Town 7505 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Harry Crossley Foundation Francie van Zyl Drive, Parow Cape Town 7500 South Africa
Harry Crossley Foundation Cape Town South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Stellenbosch University Francie van Zijl Drive, Parow Cape Town 7500 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Helen McIlleron Department of Pharmacology, University of Cape Town 7945 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Penelope Rose pcrose@sun.ac.za 27219389177 Clinical Building, Francie van Zyl Drive, Parow
City Postal code Country Position/Affiliation
Cape Town 7505 South Africa Research Clinician
Role Name Email Phone Street address
Public Enquiries Anthony Garcia-Prats garciaprats@sun.ac.za 27219389177 Clinical Building, Francie van Zyl Drive, Parow
City Postal code Country Position/Affiliation
Cape Town 7505 South Africa Research Clinician
Role Name Email Phone Street address
Scientific Enquiries Anneke Hesseling pcrose@sun.ac.za 27219389177 Clinical Building, Francie van Zyl Drive, Parow
City Postal code Country Position/Affiliation
Cape Town 7505 South Africa Director Paediatric TB Research Program, Desmond Tutu TB Centre
REPORTING
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