Skip to content

Influence of Lignocaine on the Tolerability and Pharmacokinetics of Intramuscular Amikacin: A Double-Blind Randomised Cross-Over Trial

Influence of Lignocaine on the Tolerability and Pharmacokinetics of Intramuscular Amikacin: A Double-Blind Randomised Cross-Over Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR201401000670381
Enrollment
12
Registered
2013-10-07
Start date
2013-07-01
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis

Interventions

Sponsors

Stellenbosch University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
The change in pain intensity achieved when lignocaine is co-administered with intramuscular injection of amikacin, as measured by the FACES pain scale

Secondary

MeasureTime frame
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

Countries

South Africa

Contacts

Public ContactAnthony Garcia-Prats

Research Clinician

garciaprats@sun.ac.za27219389177

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Feb 4, 2026