Adverse drug reactions in paediatric patients in a tertiary care hospital in India: a prospective observational single centre study

Background: Adverse drug reactions (ADRs) are a major source of concern in adult and paediatric population. Monitoring ADRs in children is vital as they differ from adults in pharmacokinetic and pharmacodynamics responses. Strict ethical guidelines in clinical trials result in extrapolation of data from studies done in adults. Further, ADRs reported in adults do not predict those in children. Incidence of ADRs in children is 2.9% emphasizing the need for systematic monitoring. Studies at institutional level can generate valuable data among paediatric population. Hence, the current study was taken up to assess the clinical pattern of ADRs, their causality, severity and preventability.Methods: This is a prospective observational single centre study. Suspected cases of ADRs were collected and assessed for the clinical pattern, causality, severity and preventability factors along with gender-wise distribution.Results: A total of 118 ADRs were reported in our study. Most of the ADRs (46.67%) occurred below 1 year of age with male preponderance (53.4%). Skin was the most common organ involved (91.5%). Majority (78.8%) of ADRs were due to anti-infectives for systemic use (J). Vaccines were the most commonly implicated agents (55.9%) followed by antibiotics (22.9%). Severe reaction like DRESS syndrome was reported due to antiepileptics (including levetiracetam) requiring hospitalisation. Majority of ADRs were probable (92.4%), moderate (73.7%) and definitely preventable (61%).Conclusions: A wide range of ADRs are possible in paediatric population. Adequate knowledge about ADRs is essential and caution has to be exercised even while prescribing drugs which are considered safe in children

Insight into Usefulness of Anterior Rhinomanometry as Marker in Adenoid Hypertrophy

INTRODUCTION Prospective Observational Study in 34 Patients from December 2018 till November 2022 in Tertiary Care Hospital to objectively assess diagnostic utility of anterior rhinomanometry in symptomatic patients undergoing Adenoidectomy preoperatively and postoperatively and subjectively compare changes in quality of life. MATERIALS AND METHODS Patients with clinical history of adenoid hypertrophy managed clinically for 2 months, posted for adenotonsillectomy were performed Anterior Rhinomanometry using M/s GENESIS MEDICAL SYSTEMS NASOBALANCE – P 5 to calculate both baseline and post decongestion resistance values. Postoperatively anterior rhinomanometry is performed after 12 weeks and compared with preoperative nasal resistance values. Quality of Life measured by Visual Analogue Scale. RESULTS Comparison of Preop post decongestion and postop pre decongestion of nasal resistance following adenoidectomy revealed nasal resistance significantly reduced (p<0.05). When nasal resistance preoperatively compared with X ray nasopharynx there was proportionate increase in nasal resistance as soft tissue narrowing of airway increases. CONCLUSION          Visual Analogue Scale reveals improvement of quality of life in 28/34 = 82.35% patients. Comparison of Pre and post decongestion values following adenoidectomy in isolated asymptomatic patients revealed p value is insignificant which is established by anterior rhinomanometry suggesting values of nasal airway resistance remained similar in isolated adenoid hypertrophy patients