David M. Golding MBBCh, BSc, PGDip , Tak Wai Chan BMedSci, BMBS , Nikola G. Orozov MPharm, PGDipClinPharm , Paul J. Young MBChB, PhD
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Masking of an intravenous preparation of ceftriaxone for use in clinical trials: A technical report
Background
Intravenous antibiotics are often evaluated in clinical trials in hospitalised patients but for blinded trials masking of antibiotics is required.
Objective
To evaluate the effectiveness of masking of ceftriaxone and amoxicillin / clavulanic acid for use in blinded clinical trials.
Design, setting, and participants
Amoxicillin / clavulanic acid (1.2g) and ceftriaxone (1g and 2g) were diluted in 100mL of sodium chloride. Clinicians from a single centre were asked to attempt to distinguish solutions containing antibiotics from solutions without added antibiotics at time points up to 12 hours following dilution.
Results
1g of ceftriaxone diluted in 100 mL of 0.9 sodium chloride stored in a light-protected bag and refrigerated at 3–4 °C for up to 10 h could not readily be distinguished from 100 mL of 0.9 % sodium chloride. However, solutions containing either amoxicillin / clavulanic acid (1.2g) or ceftriaxone (2g) were readily identifiable.
Conclusions
1 g of ceftriaxone can be effectively masked by dilution in 100mL of sodium chloride.
期刊介绍：
ritical Care and Resuscitation (CC&R) is the official scientific journal of the College of Intensive Care Medicine (CICM). The Journal is a quarterly publication (ISSN 1441-2772) with original articles of scientific and clinical interest in the specialities of Critical Care, Intensive Care, Anaesthesia, Emergency Medicine and related disciplines.
The Journal is received by all Fellows and trainees, along with an increasing number of subscribers from around the world.
The CC&R Journal currently has an impact factor of 3.3, placing it in 8th position in world critical care journals and in first position in the world outside the USA and Europe.
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