As part of the vamorolone phase 2b study, children will be asked to swallow some tablets/pills every morning for the first 6 months. In view of the young age of the children recruited in this study, swallowing tablets might be seen as a challenge. Some children might have never tried to swallow tablets and both the child and the parents might be worried the child will not be able to do it.
The ability to swallow tablets is an inclusion criteria for the study and has to be confirmed in clinic during the screening period and before randomization. Learning how to take tablets might have several advantages for the child and the family beyond the study.
Dr Emma Lim, Consultant Paediatrician at the Great North Children Hospital, Newcastle upon Tyne UK, has developed this teaching technique.
Initial assessment
Prior to assessing the ability of the child to swallow tablets, a thorough discussion with the parents/legal guardians who will administer the tablets to the child is paramount. This should include:
- Previous experience with tablet swallowing
- Child general behavioural (e.g. cooperation, temper, increased anxiety, attitude towards authority, motivation to learn new skills)
- Child behaviour towards food and medicine
- Any neuro-cognitive difficulties affecting swallowing
- Any allergy or hypersensitivity
- Placebo tablets must be obtained by the Sponsor as part of the study. Sweats (e.g. “100 and 1000s sprinkles” or “tic tac”) can be used for training purposes only
Where possible, the person carrying out the technique should be emotionally neutral to the child (e.g. study nurse). An individual seen as an authority figure could create an anxiety-producing situation for the child. The child might feel less anxious and reassured with the presence of a parent in the room. A flexible approach and professional judgement is recommended.
Setting the scene
- The child should not feel under pressure to succeed and should be allowed to practice at home
- Training sessions should not last more than 20 min
- Assess parent/guardianʼs anxiety, expectations, and feelings with regards to failure
- Discuss with child and/or parent/guardian whether or not parent/guardian would be in the room during the training session
- Encourage the child to use the toilet before the session commences
- The room should be free from distractions (e.g. TV, toys, books)
- A sign on the door will help prevent interruptions.
The process
- Sit on a chair, with the child sat across from you at a small table
- Talk enthusiastically and explain that the child will learn something new
- Remind the child about learning new skills (dressing, eating)
- Do not mention any future treatment and avoid any discussion irrelevant to the session
- Positive feedback is always welcome (e.g. “can’t wait to see you swallowing tablets”)
- Use short commands and repeat as many times as necessary
- Allow them to select their favourite liquid to drink (cold)
- Present the tablets/pills to the child one at a time; one could also present 2 tablets (same size) and let the child choose which tablet he wants to swallow.
- Allow the child to choose the trainers tablet putting them in control
- Placebo containers should be kept out of sight.
Before the first attempt, encourage the child to swallow some liquid. This will help identify any problems the child experiences with swallowing.
The steps
Demonstrate the steps to tablet swallowing as follows:
- Sit or stand up straight
- Take a deep breath
- The study Sponsor provides placebo tablets which have the same size as the tablets used in the study; it might be useful to start with smaller size and increase size as appropriate. For smaller size tablets, a small sweet such as “100 and 1000s sprinkles” or “tic tac” can be used
- Put the tablet in the middle of the tongue
- Drink liquid from bottle (or cup) keeping head straight.
If the child succeeds, move quickly to “the next pill” (not “bigger pill”), praising the child each time. Do not reassure or give multiple commands to the child if he/she does not manage to swallow the tablet (regardless of the size). Keep calm and allow the child to swallow the water (“that’s OK, keep drinking!”).
Ignore the child while swallowing the tablet but pay attention and praise when they have completed the task. After several unsuccessful attempts, allow the child to decide whether he/she wants to persist in trying to swallow the pill.
Encourage the child to repeat taking the tablet from the previous successful attempt finishing session on a positive and provide positive feedback about the session. (It is important to end the session with success on either a smaller tablet or even just liquid and praise the child for their effort.)
A sticker/certificate as a reward (when appropriate) is always appreciated.
Finally
At the end of the session, allow the child to
show off their new skill (with largest tablet taken). Instruct the
parents to sit to one side quietly, withholding comments or praise until the child
swallows successfully.Some parents may also be on treatment and could
be identified as a role model to the child with shared responsibility.
If the parents are supportive and keen to be involved, send them home with
enough placebo pills so that they can practice at home.The parents/guardians
should be supplied with written instructions to that they can practice with the
child. Parents are advised to stop practicing if the child experiences any
problems with tablet swallowing (placebos) at home so that negative experiences
are kept to a minimum.
Contact details should also be given to the parents in case they have any
problems or questions
Hot tips for parents
- It really helps your child for you to show them how pleased you are that they have taken their medicines
- It is important to be firm and consistent but avoid power battles, punishments and threats
- Give more control to the child (e.g. drink choice, do they want to take tablets or liquid solution first)
- Use stories (such as waterfall that washes pebble away)
- Make the process a fun experience
- Try not to bargain, or bribe the child
- Avoid tricking the child with food (e.g. hiding the tablet)
- Use food to reduce taste or help with swallowing (e.g. jelly, milk, cold drink, ice cream, yoghurt)
- Avoid thick liquid that could slow down swallowing process.
- Be firm in telling your child it is time for medicine (e.g. no other activities)
- Remind parents of the importance to report to the medical team if the child does not adhere to the treatment.
This technique increases a child’s confidence to swallow pills and enables them to have more control over their treatment which could help improve adherence to therapy.
Authors and references
Modified and updated for generic use by Sister Ailsa Pickering, Great North Children’s Hospital, Newcastle Upon Tyne, UK Previous authors: Djamel Hamadache (based on original by Stephen Head). This protocol was adapted by the St. Mary’s Hospital Family Clinic Team, London, from the method originally described by Mark Kline and colleagues, Houston, Texas.
- Bryon M, ʻAdherence to treatment in childrenʼ in Myers LB & Midence K, eds, Adherence to treatment in medical conditions, Harwood Academic Publishers, 1998. Chap 7, pp. 161-190.
- Garvie PA, Lensing S, Rai SN, Efficacy of a pill-swallowing training intervention to improve antiretroviral medication adherence in pediatric patients with HIV/AIDS. Pediatrics, 2007, 119 (4) pp 893-9.
- Meltzer EO, Welch MJ, Ostrom NK. Tablet swallowing ability and training in children 6 to 11 years of age. Clin Pediatrics, 2006, 45 (8) pp 725-33.
- Czyzewski DI, Runyan RD, Lopez MA, Calles NR, Teaching and maintaining tablet swallowing in HIV infected children. AIDS, 2000, 10 (2).
- Baylor International Pediatric AIDS Initiative (2009) Primer on tablet swallowing. http://bayloraids.org/resources/pillprimer/
