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Can children swallow tablets? Outcome data from a feasibility study to assess the acceptability of different-sized
Louise Bracken1, Emma McDonough1, Samantha Ashleigh2
1Paediatric Medicines Research Unit, Alder Hey Children's NHS Foundation Trust, Liverpool, UK.
Insights
This study found that 8mm placebo tablets are the most acceptable for children aged 4-12 years. While younger children found larger tablets easier to swallow, taste was rated highly across all age groups.
Area of Science:
- Pediatric Pharmacology
- Pharmaceutical Formulation
- Clinical Feasibility Studies
Background:
- Tablet acceptability in pediatric populations is crucial for medication adherence.
- Different tablet sizes and formulations present unique swallowing challenges for children.
- Limited data exists on the optimal tablet size for pediatric administration.
Purpose of the Study:
- To assess the feasibility and acceptability of different-sized placebo tablets in children aged 4-12 years.
- To determine the most acceptable tablet size for pediatric patients.
- To inform the design of future pediatric medication trials.
Main Methods:
- A feasibility study conducted in pediatric hospital settings.
- Participants (children aged 4-12) were given 6mm, 8mm, and 10mm placebo tablets.
- Swallowing behavior, water consumption, and questionnaire-based acceptability (swallowability, taste) were assessed and stratified by age (4-8 and 9-12 years).
Main Results:
- The 8mm tablet size was deemed most acceptable by all participants.
- Younger children (4-8 years) found larger tablets easier to swallow but required more water.
- Older children (9-12 years) showed minimal preference for tablet size but increased water consumption with larger tablets.
Conclusions:
- Tablets represent a potentially acceptable formulation for pediatric patients aged 4-12 years.
- The 8mm tablet size is recommended for this age group based on acceptability.
- Recruitment strategies for pediatric medication acceptability studies require careful consideration, with recruitment of staff children proving effective.
Objective:
Feasibility study to investigate the acceptability of different-sized placebo tablets in children aged 4-12 years.
Design And Setting:
Clinical Research Facilities, inpatient wards and outpatient clinics within a Regional Paediatric Hospital and/or District General Hospital. Healthy children and National Health Service (NHS) patients were asked to swallow three placebo tablets: 6 mm, 8 mm and 10 mm, smallest to largest. The researcher observed children's facial expressions and behaviours on swallowing and measured the volume of water consumed. Participants completed a questionnaire about the overall acceptability; including swallowability, taste and volume of water consumed. For analysis, participants were stratified by age: 4-8 years and 9-12 years.
Results:
The feasibility study led to an estimated recruitment rate of 0.8% for NHS inpatients and 211 healthy children over a 1-year period. In total, 55 participants were recruited, 30 to the younger group, of which 77% had never taken a tablet before. 84% of the 25 older children had previously taken a tablet. All participants attempted to swallow the smallest sized tablet. The children aged 4-8 years found the larger tablets easier to swallow, however the older children found little difference between the tablet sizes. The younger children required more water to swallow each tablet size compared with the older children where an increasing volume of water was consumed as tablet size increased. Taste was rated highly for both age groups. The 8 mm tablets were deemed the most acceptable tablet size by all participants.
Conclusion:
Tablets are potentially an acceptable formulation for children aged 4-12 years. Most children aged 4-8 years who attempted to swallow tablets successfully did so. Recruitment of NHS inpatients to medicine acceptability studies is challenging, however, recruitment of children of staff proved an effective strategy. Valuable lessons have been learnt from this feasibility study which will inform the design of a larger definitive trial.
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