Influence of Lignocaine on the Tolerability and Pharmacokinetics of Intramuscular Amikacin: A Double-Blind Randomised Cross-Over Trial
Not Applicable
Recruiting
- Conditions
- Tuberculosis
- Registration Number
- PACTR201401000670381
- Lead Sponsor
- Stellenbosch University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
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
Exclusion Criteria
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The change in pain intensity achieved when lignocaine is co-administered with intramuscular injection of amikacin, as measured by the FACES pain scale
- Secondary Outcome Measures
Name Time Method Local or systemic adverse effects occurring when lignocaine is administered together with amikacin in an intramuscular injection;The bioavailability of amikacin when co-administered with lignocaine as an intramuscular injection