Sandy M Hopper1, Michelle McCarthy2, Chasari Tancharoen3, Katherine J Lee4, Andrew Davidson5, Franz E Babl6. 1. Department of Emergency Medicine, Royal Children's Hospital, Parkville, Victoria, Australia; Murdoch Children's Research Institute, Parkville, Victoria, Australia. Electronic address: sandy.hopper@rch.org.au. 2. Department of Emergency Medicine, Royal Children's Hospital, Parkville, Victoria, Australia. 3. Department of Paediatrics, Faculty of Medicine, Dentistry, and Health Sciences, University of Melbourne, Victoria, Australia; Junior Medical Staff Department, St Vincent's Hospital, Fitzroy, Victoria, Australia. 4. Murdoch Children's Research Institute, Parkville, Victoria, Australia; Department of Paediatrics, Faculty of Medicine, Dentistry, and Health Sciences, University of Melbourne, Victoria, Australia. 5. Department of Anaesthesia and Pain Management, Royal Children's Hospital, Parkville, Victoria, Australia; Murdoch Children's Research Institute, Parkville, Victoria, Australia; Department of Paediatrics, Faculty of Medicine, Dentistry, and Health Sciences, University of Melbourne, Victoria, Australia. 6. Department of Emergency Medicine, Royal Children's Hospital, Parkville, Victoria, Australia; Murdoch Children's Research Institute, Parkville, Victoria, Australia; Department of Paediatrics, Faculty of Medicine, Dentistry, and Health Sciences, University of Melbourne, Victoria, Australia.
Abstract
STUDY OBJECTIVE: We establish the efficacy of 2% viscous lidocaine in increasing oral intake in children with painful infectious mouth conditions compared with placebo. METHODS: This was a randomized placebo-controlled trial of viscous lidocaine versus placebo at a single pediatric emergency department. Study staff, clinicians, nurses, caregivers, and participants were blinded to the group assignment. Children with acute infectious ulcerative mouth conditions (gingivostomatitis, ulcerative pharyngitis, or hand, foot, and mouth disease) and poor oral fluid intake were randomized to receive 0.15 mL/kg of either 2% viscous lidocaine or placebo with identical appearance and flavor. The primary outcome was the amount of fluid ingested in the 60 minutes after administration of the intervention, with a difference in intake of 4 mL/kg considered clinically important. Secondary outcomes were specific milliliter per kilogram fluid targets and incidence of adverse events. RESULTS:One hundred participants were recruited (50 per treatment group), all of whom completed the 60-minute fluid trial period. Oral intake 1 hour after drug administration was similar in both groups: lidocaine median 8.49 mL/kg (interquartile range 4.07, 13.84 mL/kg) versus placebo 9.31 mL/kg (interquartile range 3.06, 15.18 mL/kg); difference in medians 0.82 mL/kg (95% confidence interval -2.52 to 3.26); Mann-Whitney P=.90. Likewise, short-term secondary outcomes were similar between the groups and there were no adverse events in either group. CONCLUSION:Viscous lidocaine is not superior to a flavored gel placebo in improving oral intake in children with painful infectious mouth ulcers.
RCT Entities:
STUDY OBJECTIVE: We establish the efficacy of 2% viscous lidocaine in increasing oral intake in children with painful infectious mouth conditions compared with placebo. METHODS: This was a randomized placebo-controlled trial of viscous lidocaine versus placebo at a single pediatric emergency department. Study staff, clinicians, nurses, caregivers, and participants were blinded to the group assignment. Children with acute infectious ulcerative mouth conditions (gingivostomatitis, ulcerative pharyngitis, or hand, foot, and mouth disease) and poor oral fluid intake were randomized to receive 0.15 mL/kg of either 2% viscous lidocaine or placebo with identical appearance and flavor. The primary outcome was the amount of fluid ingested in the 60 minutes after administration of the intervention, with a difference in intake of 4 mL/kg considered clinically important. Secondary outcomes were specific milliliter per kilogram fluid targets and incidence of adverse events. RESULTS: One hundred participants were recruited (50 per treatment group), all of whom completed the 60-minute fluid trial period. Oral intake 1 hour after drug administration was similar in both groups: lidocaine median 8.49 mL/kg (interquartile range 4.07, 13.84 mL/kg) versus placebo 9.31 mL/kg (interquartile range 3.06, 15.18 mL/kg); difference in medians 0.82 mL/kg (95% confidence interval -2.52 to 3.26); Mann-Whitney P=.90. Likewise, short-term secondary outcomes were similar between the groups and there were no adverse events in either group. CONCLUSION: Viscous lidocaine is not superior to a flavored gel placebo in improving oral intake in children with painful infectious mouth ulcers.
Authors: Simon S Craig; Robert W Seith; John A Cheek; Adam West; Kathryn Wilson; Diana Egerton-Warburton Journal: Trials Date: 2015-01-27 Impact factor: 2.279