Abstract:

Introduction: The common cold affects children frequently, with 7-10 episodes annually, imposing significant economic and social burdens. Early management to reduce symptom severity and duration is crucial.

Objective: To evaluate the safety and efficacy of a fixed dose combination (FDC) syrup containing paracetamol, phenylephrine, and chlorpheniramine, for treating common cold symptoms in children aged 6- 18 years.

Methods: The study was conducted in India from March 2021 to December 2022, included 200 children aged 6 to <18 years with cold symptoms lasting 6-72 hours. They received paracetamol 250 mg, phenylephrine hydrochloride 5 mg, and chlorpheniramine maleate 2 mg per 5mL syrup for 5 days. For safety evaluation, the incidence of adverse events and the tolerability of study treatment were assessed, while improvement in common cold symptoms and complete resolution were assessed to evaluate the efficacy of the study treatment.

Results: One patient reported mild drowsiness unrelated to the study drugs. Treatment was well-tolerated, with "good to excellent" responses reported by 94% (parents) and 95% (investigators). Symptom severity significantly decreased by day 5 (p<0.001), with total symptom scores reducing from 9.12 to 0.13 (mean diff: 8.99, 95%CI: 7.86-10.12; p<0.001). 92% of patients showed complete symptom resolution by study end, with no symptom worsening.

Conclusion: The FDC of paracetamol, phenylephrine, and chlorpheniramine syrup effectively managed common cold symptoms in children aged 6 years and older, demonstrating good tolerability.