A mini-review of non-parenteral clonidine preparations for paediatric sedation

Abstract

Objective To provide an overview of non-parenteral clonidine formulations and assess the feasibility of their use for paediatric sedation. Methods A literature search was conducted using electronic databases and a combination of search terms. Forty articles met the inclusion criteria. Publications were grouped into different dosage forms and assessed for their potential application for sedation of children in intensive care. Key findings Several routes of clonidine administration have been investigated for numerous indications in children, including perioperative sedation and analgesia. These include oral liquids, tablets, oral transmucosal systems, nasal sprays and rectal suspensions. Conflicting studies on oral transmucosal clonidine formulations suggest that further research is required to fully establish efficacy. Nasal sprays and rectal suspensions have the advantages of rapid onset of action and potential for dose flexibility, but predictable absorption is difficult to obtain. Conclusions Provided age-appropriate strengths are available, intravenous formulations remain the most predictable in terms of bioavailability and flexible in terms of dose adjustment. However, as with all routes, down-titration is difficult given the long half-life of clonidine. Oral transmucosal systems, nasal sprays and rectal suspensions have potential in a less acute setting, but significant clinical work is required to elucidate a full pharmacokinetic and pharmacodynamic profile.

Stability of clonidine hydrochloride in an oral powder form compounded for pediatric patients in Japan

“…A literature review by Hanning et al [ 27 ] also noted that the use of solid oral clonidine formulations for pediatric sedation has not been reported; however, liquid oral clonidine formulations are used for non-parenteral administration in a pediatric intensive care unit setting, offering dose flexibility. The stability of a liquid clonidine formulation was maintained at room temperature for over 270 days in a 50-mg/mL extemporaneous aqueous clonidine hydrochloride solution containing saccharin, raspberry, and methylparaben and buffered at pH 5 [ 12 ].…”