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Stability of Ketamine–Propofol Mixtures for Procedural Sedation and Analgesia in the Emergency Department

2008; Canadian Society of Hospital Pharmacists; Volume: 61; Issue: 6 Linguagem: Inglês

10.4212/cjhp.v61i6.99

1920-2903

Ronald F Donnelly, Elaine Willman, Gary Andolfatto,

Anesthesia and Neurotoxicity Research

ABSTRACT Background: The mixture of ketamine and propofol administered together is reportedly an effective agent for procedural sedation and analgesia in the emergency department. However, the physical compatibility and chemical stability of extemporaneous solutions prepared from generic formulations of the drugs are not known. Objective: To investigate the physical compatibility and chemical stability of 50:50 and 30:70 mixtures of generic ketamine and propofol packaged in polypropylene syringes and stored at room temperature (23°C) with exposure to light. Methods: Mixtures of ketamine (10 mg/mL) and propofol emulsion (10 mg/mL) were prepared at 50:50 and 30:70 ratios, packaged in capped polypropylene syringes (3 syringes for each mixture), and stored at room temperature with exposure to light. One sample from each syringe was analyzed in duplicate at time 0 and after 1 and 3 h. Physical changes such as pH, separation or cracking of the emulsion, change in colour, and formation of gas were monitored. The chemical stability of each drug was assessed by high-performance liquid chromatography. Results: Both mixtures of ketamine and propofol were physically compatible during storage for up to 3 h. There were no signs of change in any of the physical parameters during the 3-h study. Each drug retained at least 97% of its original concentration. Conclusion: Mixtures of ketamine and propofol at 50:50 and 30:70 ratios were physically compatible and chemically stable for up to 3 h when stored in capped polypropylene syringes at room temperature with exposure to light. RESUME Contexte : L’association ketamine-propofol semble etre efficace pour induire une sedation et une analgesie d’intervention aux urgences. Cependant, on ne connait pas la compatibilite physique et la stabilite chimique des solutions extemporanees de cette association, preparees a partir des generiques de ces deux medicaments. Objectif : Analyser la compatibilite physique et la stabilite chimique de melanges 50:50 et 30:70 de ketamine et de propofol generiques conditionnes dans des seringues de polypropylene qui ont ete conservees a la temperature ambiante (23°C) et exposees a la lumiere. Methodes : Des melanges de ketamine (10 mg/mL) et de propofol en emulsion (10 mg/mL) ont ete prepares dans des rapports de 50:50 et 30:70, puis conditionnes dans des seringues de polypropylene munies d’un capuchon (3 seringues pour chaque melange) qui ont ete entreposees a la temperature ambiante et exposees a la lumiere. Un echantillon de chaque seringue a subi une double analyse au temps 0, puis apres 1 et 3 heures. Chaque echantillon a ete examine a la recherche de changements physiques, notamment les changements de pH, la separation de l’emulsion, le changement de couleur et la formation de gaz. La stabilite chimique de chaque medicament a ete determinee par chromatographie liquide haute performance. Resultats : Les deux melanges de ketamine et de propofol etaient physiquement compatibles durant l’entreposage pendant une periode allant jusqu’a 3 heures. Aucun signe de changement dans aucun des parametres physiques n’a ete observe pendant la periode d’etude de 3 heures. Chaque medicament a conserve au moins 97 % de sa concentration initiale. Conclusion : Les melanges de ketamine et de propofol dans un rapport de 50:50 et de 30:70 etaient physiquement et chimiquement stables pendant une periode allant jusqu’a 3 heures, lorsqu’ils etaient entreposes dans des seringues de polypropylene munies d’un capuchon, a la temperature ambiante, et exposees a la lumiere.