None listed
Conditions
Brief summary
People having issues swallowing their medications may crush it and mix with food or drinks. In aged care homes and for dysphagic patients it is common to thicken water with commercial thickening agents to provide the correct viscosity to enable swallowing. In an in vitro study, we have found that drug dissolution was consistently reduced when the tablets were crushed and mixed with a commercially available thickened fluid consisting of xanthan gum and maltodextrin. It was observed that mixing crushed tablets with thickened fluid caused prolonged dissolution time compared to other mixers (water, jam, yogurt, honey and juice) and compared to dissolution of the whole tablet. Based on our in vitro data, we hypothesise that the rate of drug absorption will be significantly slowed, and the maximum drug concentration reached will be reduced when a drug is crushed and mixed with the thickened fluid in comparison to the whole tablet, crushed tablet delivered in water, and crushed tablet mixed with jam.
Interventions
This is a randomized study, on arrival at the venue participants (20 healthy volunteers) will receive a standard dose of 1 g paracetamol (two 500 mg tablets), and will receive one of the following treatments.
Treatment 1: Tablets will be swallowed whole with 250 ml of water.
Treatment 2: Tablets will be swallowed whole with 250 ml of water.
Treatment 3: Tablets that have been crushed and mixed with 100 ml of water will be swallowed, followed by another 150 ml water to be used to rinse the mou
This is a randomized study, on arrival at the venue participants (20 healthy volunteers) will receive a standard dose of 1 g paracetamol (two 500 mg tablets), and will receive one of the following treatments. Treatment 1: Tablets will be swallowed whole with 250 ml of water. Treatment 2: Tablets will be swallowed whole with 250 ml of water. Treatment 3: Tablets that have been crushed and mixed with 100 ml of water will be swallowed, followed by another 150 ml water to be used to rinse the mouth during swallowing. Treatment 4: Tablets that have been crushed and mixed with a commercial thickened fluid (15 g EasyThick) will be swallowed, followed by 250 ml water to be used to rinse the mouth during swallowing. Treatment 5: Tablets that have been crushed and mixed with jam (15 g) will be swallowed, followed by 250 ml of water to be used to rinse the mouth during swallowing. Washout period : 7 days
Sponsors
A/Prof Kathryn Steadman
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Male or Female Age 18 to 65 years Participant has had previous exposure to paracetamol with no adverse events. Participants understand and voluntarily agree to participate in this study by providing written consent.
Exclusion criteria
Previous history of allergy or sensitivity to paracetamol Consumed paracetamol in the last 24 hours before the study People for whom paracetamol treatment is contraindicated or for whom paracetamol safety and disposition could be altered (e.g. hepatic dysfunction) Smokers Pregnancy Consumed food within 2 hour prior to the start of the study
Outcome results
None listed