Oral Syringe Versus Drug Pacifier for Delivery of Oral Antipyretic Medication: A Randomized Controlled Trial

Abstract

Introduction

Fever is 1 of the most common symptoms in children, and oral paracetamol is 1 of the most preferred antipyretic and analgesic agents for treating fever. Administering the full dose is key to effectively managing symptoms, which necessitates a method to prevent dose loss. This study compared 2 different drug delivery methods used for oral paracetamol administration in terms of clinical efficacy.

Methods

After obtaining ethical approval, the study was conducted with 100 eligible children aged 0 to 24 months who presented to a university hospital pediatrics department between January 2021 and February 2022. The children were randomly assigned to the drug pacifier (n = 50) and oral syringe groups (n = 50). Data were collected using a patient information form and the Face, Legs, Activity, Cry, and Consolability pain scale. Vital signs were recorded before and 15, 30, 45, and 60 minutes after drug administration. In addition, Face, Legs, Activity, Cry, and Consolability pain scores were recorded by a parent, researcher, and nurse observer at the same time points. The observer nurse also noted any spillage of the drug during oral administration by the nurse to the children in both groups. (Clinical Trial Registry: NCT05366049)

Results

There was no significant difference between the groups in terms of body temperature before or after drug administration (P>.05). Heart rate and respiratory rate were significantly lower in the drug pacifier group starting at minute 30 (P<.05). Oxygen saturation was significantly higher in the drug pacifier group from minute 45 (P = .001). In pain comparisons, there was no significant difference between the groups in the mean scores given by the parent, nurse observer, and researcher before drug administration, whereas the drug pacifier group had statistically significantly lower pain scores than the oral syringe group at all post-drug administration time points (15, 30, 45, and 60 minutes) (P<.05). Interobserver agreement was high at all measurement times.

Discussion

Using a drug pacifier for paracetamol, drug administration was more effective in delivering the target drug dose. Given the higher dose accuracy and positive effect on vital signs, we recommend using the drug pacifier in very young children.