TITLE: Enemas for the Treatment of Constipation in the Emergency Department: Clinical Effectiveness and Guidelines DATE: 23 February 2015 RESEARCH QUESTIONS 1. What is the clinical effectiveness and harms of enemas for patients presenting with constipation and fecal impaction in the emergency department? 2. What are the evidence-based guidelines regarding the use of enemas for patients presenting with constipation and fecal impaction in the emergency department? KEY FINDINGS One randomized controlled trial, three non-randomized studies, and one evidence-based guideline were identified regarding the use of enemas for patients presenting with constipation and fecal impaction in the emergency department. METHODS A limited literature search was conducted on key resources including PubMed, The Cochrane Library (2015, Issue 2), University of York Centre for Reviews and Dissemination (CRD) databases, Canadian and major international health technology agencies, as well as a focused Internet search. No filters were applied to limit the retrieval by study type. Where possible, retrieval was limited to the human population. The search was also limited to English language documents published between January 1, 2010 and February 6, 2015. Internet links were provided, where available. The summary of findings was prepared from the abstracts of the relevant information. Please note that data contained in abstracts may not always be an accurate reflection of the data contained within the full article. Disclaimer: The Rapid Response Service is an information service for those involved in planning and providing health care in Canada. Rapid responses are based on a limited literature search and are not comprehensive, systematic reviews. The intent is to provide a list of sources of the best evidence on the topic that CADTH could identify using all reasonable efforts within the time allowed. Rapid responses should be considered along with other types of information and health care considerations. The information included in this response is not intended to replace professional medical advice, nor should it be construed as a recommendation for or against the use of a particular health technology. Readers are also cautioned that a lack of good quality evidence does not necessarily mean a lack of effectiveness particularly in the case of new and emerging health technologies, for which little information can be found, but which may in future prove to be effective. While CADTH has taken care in the preparation of the report to ensure that its contents are accurate, complete and up to date, CADTH does not make any guarantee to that effect. CADTH is not liable for any loss or damages resulting from use of the information in the report. Copyright: This report contains CADTH copyright material and may contain material in which a third party owns copyright. This report may be used for the purposes of research or private study only. It may not be copied, posted on a web site, redistributed by email or stored on an electronic system without the prior written permission of CADTH or applicable copyright owner. Links: This report may contain links to other information available on the websites of third parties on the Internet. CADTH does not have control over the content of such sites. Use of third party sites is governed by the owners’ own terms and conditions. SELECTION CRITERIA One reviewer screened citations and selected studies based on the inclusion criteria presented in Table 1. Table 1: Selection Criteria Population Intervention Comparator Outcomes Study Designs Patients presenting with constipation and fecal impaction in the emergency department Enema (any type) Any comparator (e.g., placebo, other management methods, enemas compared with each other) Clinical benefit (e.g., changes in bowel function), clinical harm Guidelines Health technology assessments, systematic reviews, meta-analyses, randomized controlled trials, non-randomized studies, evidence-based guidelines RESULTS Rapid Response reports are organized so that the higher quality evidence is presented first. Therefore, health technology assessment reports, systematic reviews, and meta-analyses are presented first. These are followed by randomized controlled trials, non-randomized studies, and evidence-based guidelines. One randomized controlled trial (RCT), three non-randomized studies, and one evidence-based guideline were identified regarding the use of enemas for patients presenting with constipation and fecal impaction in the emergency department (ED). No relevant health technology assessment reports, systematic reviews, or meta-analyses were identified. Additional references of potential interest are provided in the appendix. OVERALL SUMMARY OF FINDINGS One RCT,1 three non-randomized studies,2-4 and one evidence-based guideline5 were identified regarding the use of enemas for patients presenting with constipation and fecal impaction in the ED. All identified references were relevant to a pediatric population. The RCT1 evaluated the comparative clinical effectiveness of enema versus polyethylene glycol (PEG) 3350 for the treatment of fecal impaction in children. This study demonstrated that patients who had received an enema had significantly improved symptoms relative to PEG within three days of administration but that there was no difference between treatment groups on the fifth day post-treatment.1 The results of one retrospective cohort study2 of pediatric ED constipation cases showed that children who received an enema were significantly more likely to revisit the ED than those who did not. Two non-randomized studies3,4 examined the clinical effectiveness and safety of the milk and molasses enema. One retrospective chart review3 of pediatric patients presenting to the ED with constipation or abdominal pain revealed that the majority of patients treated with a milk and molasses enema experienced relief from constipation, and that the success rate was associated with patient age and enema volume. The authors added that the enemas had minimal side Enemas for the Treatment of Constipation in the Emergency Department 2 effects.3 Another study showed that there were no significant differences in patient outcomes between milk and molasses enemas and sodium phosphate enemas for the treatment of pediatric constipation.4 In a National Institute for Health and Clinical Excellence (NICE) guideline for the management of pediatric constipation in primary and secondary care,5 enemas are not recommended for firstline treatment of fecal disimpaction but are listed as an option for cases in which all oral medications have failed. Recent evidence of the similar clinical effectiveness of oral laxatives and enemas for fecal disimpaction that was cited in the guideline update has not altered this recommendation.5 Enemas for the Treatment of Constipation in the Emergency Department 3 REFERENCES SUMMARIZED Health Technology Assessments No literature identified. Systematic Reviews and Meta-analyses No literature identified. Randomized Controlled Trials 1. Miller MK, Dowd MD, Friesen CA, Walsh-Kelly CM. A randomized trial of enema versus polyethylene glycol 3350 for fecal disimpaction in children presenting to an emergency department. Pediatr Emerg Care. 2012 Feb;28(2):115-9. PubMed: PM22270500 Non-Randomized Studies 2. Freedman SB, Thull-Freedman J, Rumantir M, Eltorki M, Schuh S. Pediatric constipation in the emergency department: evaluation, treatment, and outcomes. J Pediatr Gastroenterol Nutr. 2014 Sep;59(3):327-33. PubMed: PM24796805 3. Wallaker K, Fortuna E, Bradin S, Macy M, Hassan M, Stanley R. Milk and molasses enemas: clearing things up. J Emerg Nurs. 2014 Nov;40(6):546-51. PubMed: PM24182894 4. Hansen SE, Whitehill JL, Goto CS, Quintero CA, Darling BE, Davis J. Safety and efficacy of milk and molasses enemas compared with sodium phosphate enemas for the treatment of constipation in a pediatric emergency department. Pediatr Emerg Care. 2011 Dec;27(12):1118-20. PubMed: PM22134228 Guidelines and Recommendations 5. Constipation in children and young people: evidence update June 2012 [Internet]. London (UK): National Institute for Health and Clinical Excellence (NICE); 2012 Jun [cited 2015 Feb 19]. Available from: http://www.nice.org.uk/guidance/cg99/evidence/cg99-constipation-in-children-and-youngpeople-evidence-update2 See: Faecal disimpaction, page 7 PREPARED BY: Canadian Agency for Drugs and Technologies in Health Tel: 1-866-898-8439 www.cadth.ca Enemas for the Treatment of Constipation in the Emergency Department 4 APPENDIX – FURTHER INFORMATION: Systematic Reviews and Meta-analyses – Unclear Setting 6. Tabbers MM, Boluyt N, Berger MY, Benninga MA. Constipation in children. BMJ Clin Evid [Internet]. 2010 Apr 6 [cited 2015 Feb 12];2010. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2907595 PubMed: PM21718570 Non-Randomized Studies – Alternate Comparator 7. Niv G, Grinberg T, Dickman R, Wasserberg N, Niv Y. Perforation and mortality after cleansing enema for acute constipation are not rare but are preventable. Int J Gen Med [Internet]. 2013 Apr 26 [cited 2015 Feb 12];6:323-8. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3641812 PubMed: PM23658492 Guidelines and Recommendations Unclear or Alternate Setting 8. Tabbers MM, DiLorenzo C, Berger MY, Faure C, Langendam MW, Nurko S, et al. Evaluation and treatment of functional constipation in infants and children: evidencebased recommendations from ESPGHAN and NASPGHAN. J Pediatr Gastroenterol Nutr [Internet]. 2014 Feb [cited 2015 Feb 12];58(2):258-74. Available from: http://www.naspghan.org//files/documents/pdfs/positionpapers/Constipation_Feb_2014.pdf PubMed: PM24345831 See: 7.1 'kenlambon@bellnet.ca'Which Pharmacologic Treatment Should Be Given for Disimpaction? page 269 Recommendation 32, page 269 9. American Gastroenterological Association, Bharucha AE, Dorn SD, Lembo A, Pressman A. American Gastroenterological Association medical position statement on constipation. Gastroenterology. 2013 Jan;144(1):211-7. PubMed: PM23261064 Summarized at: http://www.guideline.gov/content.aspx?id=43610 See: What Approaches Should Be Considered for Constipation Unresponsive to Initial Approaches? Unclear Methodology 10. Constipation: emergency department clinical guidelines [Internet]. Perth (AU): Princess Margaret Hospital for Children; 2012 [cited 2015 Feb 18]. Available from: http://kidshealthwa.com/wp-content/uploads/2013/06/constipation-guideline-201206.pdf See: Treatment of Acute Constipation, page 4 Treatment of Chronic Retentive Constipation (Disimpaction), page 4 Enemas for the Treatment of Constipation in the Emergency Department 5 11. Tait A. Constipation: Starship Children’s Health clinical guideline [Internet]. Auckland (NZ): Starship Children’s Health; 2012 Feb [cited 2015 Feb 18]. Available from: http://www.adhb.govt.nz/starshipclinicalguidelines/_Documents/Constipation.pdf See: Phosphate enemas (Age >3 yrs), page 3 12. Functional constipation and soiling in children [Internet]. Ann Arbor (MI): University of Michigan Faculty Group Practice, Quality Management Program; 2008 [revised 2012; cited 2015 Feb 18]. Available from: http://www.med.umich.edu/1info/FHP/practiceguides/newconstipation/peds08.pdf See: Table 7 – Cleanout in emergency department or inpatient setting, page 7 13. The Royal Children’s Hospital Melbourne [Internet]. Melbourne (AU): Royal Children’s Hospital Melbourne; [date unknown]. Constipation; [cited 2015 Feb 20]. Available from: http://www.rch.org.au/clinicalguide/guideline_index/Constipation_Guideline/ See: Management, Disimpaction (for severe symptoms) Additional References Safety 14. Sodium phosphate/sodium biphosphate, enema. Safety considerations [Internet]. Washington (DC): VA Pharmacy Benefits Management Services, Medical Advisory Panel, VISN Pharmacist Executives; 2013 Jul [cited 2015 Feb 19]. Available from: http://www.pbm.va.gov/PBM/clinicalguidance/clinicalrecommendations/Sodium_Phosphat e_Sodium_Biphosphate_Enema_Safety_Considerations.pdf 15. Patient matters manual for public health organisations [Internet]. North Sydney (AU): NSW Government Health; [updated 2012]. Chapter 15, Nursing; [cited 2015 Feb 19]. p. 15.115.29. Available from: http://www.health.nsw.gov.au/policies/manuals/Documents/pmm-15.pdf See: Administration of Disposable Enemas – Danger from Excessive Pressure, pages 15.3-15.4 Case Study 16. Gu MM, Gonzalez CE, Todd KH. Emergent management of constipation in cancer patients. Emergency Medicine [Internet]. 2011 Nov [cited 2015 Feb 18]:6-12. Available from: http://www.emed-journal.com/fileadmin/qhi_archive/ArticlePDF/EM/043110006.pdf See: Figure 3. Algorithm for Treating Constipation in Cancer Patients in the ED, page 10 Enemas for the Treatment of Constipation in the Emergency Department 6