Sucralfate as an Adjunct to Analgesia to Improve Oral Intake in Children With Infectious Oral Ulcers: A Randomized, Double-Blind, Placebo-Controlled Trial
| Autor: | Matthew Wilkinson, Nidhi V. Singh, Giovanni A. Gabriele |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
Male
Sucralfate Placebo-controlled study Administration Oral Placebo law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Double-Blind Method law medicine Humans 030212 general & internal medicine Adverse effect Oral Ulcer Dehydration business.industry Infant 030208 emergency & critical care medicine Emergency department Analgesics Non-Narcotic Ibuprofen Anti-Ulcer Agents Acetaminophen Anesthesia Child Preschool Emergency Medicine Drug Therapy Combination Female business medicine.drug |
| Zdroj: | Annals of emergency medicine. 78(3) |
| ISSN: | 1097-6760 |
| Popis: | Study hypothesis We hypothesized that sucralfate along with oral analgesics (acetaminophen or ibuprofen) administered in the emergency department leads to a clinically significant improvement in oral intake in children with acute infectious oral ulcers. Methods This was a randomized, double-blind, placebo-controlled trial of sucralfate versus placebo conducted between 2017 and 2018 in an urban pediatric emergency department. Children aged 6 months to 5 years with acute, infectious oral ulcers and poor oral intake received either acetaminophen at 15 mg/kg or ibuprofen at 10 mg/kg and were then randomized to receive sucralfate at 20 mg/kg per dose up to 1 g or a placebo solution. The primary outcome was oral fluid intake within 60 minutes of medication administration. The secondary outcomes were repeat ED visits, length of stay in ED, intravenous hydration rate, admission rate, adverse event rate, and emergency physician’s determination of the adequacy of oral intake. Results One hundred subjects with mild dehydration (clinical dehydration score of 1) and a median age of 1.38 years were enrolled and analyzed (49 in the sucralfate group and 51 in the placebo group). Oral intake 1 hour after drug administration was similar in both the groups: the median intake in the sucralfate group was 9.7 mL/kg and 10.7 mL/kg in the placebo group (difference –1 mL/kg; 95% confidence interval [CI] −2.0 to 4.8). According to the emergency physician’s report, the secondary outcomes were significant only for adequate oral intake: 71% in the sucralfate group versus 88% in the placebo group (difference −16.8%; 95% CI −32.2 to −1.4). Conclusion Sucralfate as an adjunct to oral analgesics was not superior to placebo in improving oral intake in children with acute oral infectious ulcers. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Full Text from ScienceDirect