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Codeine versus placebo for chronic cough in children Author Gardiner, SJ, Chang, AB, Petsky, HL Published 2015 Journal Title Cochrane Database of Systematic Reviews Version Version of Record (VoR) DOI https://doi.org/10.1002/14651858.CD011914 Copyright Statement © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. This review is published as a Cochrane Review in the Cochrane Database of Systematic Reviews 2015, Issue 10. Art. No.: CD011914. Cochrane Reviews are regularly updated as new evidence emerges and in response to comments and criticisms, and the Cochrane Database of Systematic Reviews should be consulted for the most recent version of the Review. Downloaded from http://hdl.handle.net/10072/391196 Griffith Research Online https://research-repository.griffith.edu.au Cochrane Library Cochrane Database of Systematic Reviews Codeine versus placebo for chronic cough in children (Protocol) Gardiner SJ, Chang AB, Petsky HL Gardiner SJ, Chang AB, Petsky HL. Codeine versus placebo for chronic cough in children. Cochrane Database of Systematic Reviews 2015, Issue 10. Art. No.: CD011914. DOI: 10.1002/14651858.CD011914. www.cochranelibrary.com Codeine versus placebo for chronic cough in children (Protocol) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Cochrane Trusted evidence. Informed decisions. Library Better health. Cochrane Database of Systematic Reviews T A B L E O F C O N T E N T S HEADER......................................................................................................................................................................................................... 1 ABSTRACT..................................................................................................................................................................................................... 1 BACKGROUND.............................................................................................................................................................................................. 2 OBJECTIVES.................................................................................................................................................................................................. 2 METHODS..................................................................................................................................................................................................... 2 ACKNOWLEDGEMENTS................................................................................................................................................................................ 5 REFERENCES................................................................................................................................................................................................ 6 APPENDICES................................................................................................................................................................................................. 7 CONTRIBUTIONS OF AUTHORS................................................................................................................................................................... 7 DECLARATIONS OF INTEREST..................................................................................................................................................................... 7 SOURCES OF SUPPORT............................................................................................................................................................................... 8 INDEX TERMS............................................................................................................................................................................................... 8 Codeine versus placebo for chronic cough in children (Protocol) i Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Cochrane Trusted evidence. Informed decisions. Library Better health. Cochrane Database of Systematic Reviews [Intervention Protocol] Codeine versus placebo for chronic cough in children Samantha J Gardiner1, Anne B Chang1,2, Helen L Petsky1 1Queensland Children's Medical Research Institute, Queensland University of Technology, Brisbane, Australia. 2Child Health Division, Menzies School of Health Research, Charles Darwin University, Darwin, Australia Contact address: Samantha J Gardiner, Queensland Children's Medical Research Institute, Queensland University of Technology, Brisbane, Queensland, Australia. [email protected], [email protected]. Editorial group: Cochrane Airways Group Publication status and date: New, published in Issue 10, 2015. Citation: Gardiner SJ, Chang AB, Petsky HL. Codeine versus placebo for chronic cough in children. Cochrane Database of Systematic Reviews 2015, Issue 10. Art. No.: CD011914. DOI: 10.1002/14651858.CD011914. Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. A B S T R A C T This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To evaluate the safety and eGicacy of codeine (and derivatives) for the treatment of chronic cough in children. Codeine versus placebo for chronic cough in children (Protocol) 1 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Cochrane Trusted evidence. Informed decisions. Library Better health. Cochrane Database of Systematic Reviews B A C K G R O U N D drug abuse, and the risk of anaesthetic-induced anaphylaxis at the forefront of reform agendas (European Medicines Agency 2015' Description of the condition Florvaag 2012; Mattoo 1997) . Cough is a commonly-experienced symptom within the community Why it is important to do this review (Chang 2015) and was identified as the leading reason for encounters between patients and general practitioners in Australia Codeine- (and derivative-) based antitussive agents are widely between 2009 and 2010 (Britt 2010). Cough in children can be used in the paediatric population, though the mechanism of broadly categorised into acute (coughing lasting less than two action is poorly understood. The safety and eGicacy of exposure weeks) or chronic (coughing duration longer than four weeks) is highly variable, with children at increased risk of experiencing (Chang 2006; de Jongste 2003; Gibson 2010). The latter will be the significant adverse eGects (Gadomski 1992). The burden of cough subject of this review. is multifaceted and not only impacts on the relationship between children and their parents/caregivers, but also their ability to Unlike acute cough (which oKen results from a viral infection), participate fully within society due to school and work time loss the aetiology of chronic cough is diverse and may indicate a (Marchant 2008). Thus rigorously evaluating the eGicacy of various serious underlying disease such as an airway abnormality or treatment methodologies including codeine and its derivatives as bronchiectasis. Irrespective of the type of cough or its aetiology, antitussive agents will assist in clinical management and guide parents and carers oKen seek relief for their child's cough burden-reduction strategies. (Vernacchio 2008). This is not surprising as the burden of cough is multidimensional and can negatively impact individuals and their O B J E C T I V E S families (Anderson-James 2014; Marchant 2008). To evaluate the safety and eGicacy of codeine (and derivatives) for Description of the intervention the treatment of chronic cough in children. Codeine is derived from the Papaver somniferum or opium M E T H O D S poppy plant and was first extracted in 1830 by a French chemist, Pierre-Jean Robiquet (Kane 2007). Codeine is an Criteria for considering studies for this review alkaloid opiate compound and is predominantly used as an analgesic and antitussive (cough suppressant) agent in health Types of studies care. Since the discovery of codeine, numerous opiates and We will include randomised controlled trials (RCTs), quasi-RCTs semi-synthetic derivatives have been developed and utilised for and stratified RCTs that compare codeine (or derivatives) versus their antitussive properties (Kane 2007). Preparations may be placebo. We will include studies reported as full-text, those prescription controlled, but many of these drugs are readily published as abstract only, and unpublished data. available and easily accessible in combination therapies with antihistamines, antipyretics, decongestants or expectorants as Types of participants over-the-counter (OTC) non-prescription cough syrups or lozenges. Due to the diGering definitions and aetiology of chronic cough The ease of accessibility of such treatments has likely contributed between children and adults, we will only include studies with to a perception of their safety and eGicacy and has contributed to children aged 18 years or younger with a diagnosis of chronic cough widespread use within the community (Lokker 2009). (cough lasting ≥ 4 weeks). We will exclude participants with acute How the intervention might work cough. Codeine (and derivatives) has been used as an antitussive Types of interventions for centuries. The medication primarily acts through opioid We will include studies comparing medications that contain receptors of the central nervous system, though the exact codeine or codeine derivatives versus placebo. mechanisms of action are unknown (Takahama 2007). An alternative mechanism