A pilot randomised open-label taste-testing study to evaluate the acceptability of chocolate-based tramadol in children

There is a limited number of strong pain relieving medications available for children. All have their own advantages and dis-advantages. For example, anti-inflammatories, like ibuprofen, are unsuitable for those with a bleeding risk and can cause kidney damage. Morphine like drugs come with the risk of slowing breathing and a fear of diversion for illegal use. Tramadol is a medicine that has been used safely for many years in both adults and children. Its advantage is that is has similar pain relieving power to morphine like drugs in the typical dose range, but because it works in a different way, it has much less ability to impair breathing. Its main disadvantage in children is that the drug itself tastes very bitter. In adults, this is overcome by presenting the medication in capsules, so the drug is not released until it reaches the stomach. While there are some 82 registered products in Australia containing tramadol, none of them are licenced for use in children. To provide a suitable dose to small child, the standard adult dose capsule must be broken open, the drug dissolved in water, and the correct proportion given. This is cumbersome for parents, risks error in dosing and produces a horrible tasting solution that most children dislike. There is one preparation available (although not licensed for use in children) of very concentrated oral drops, 1ml containing 100mg of drug, equal to 2 standard capsules. This is unsuitable for young children because the risk of overdose with such a concentrated solution is great, and has occurred with this formulation. To make drugs more palatable to young children they are often dissolved in syrup, but this only masks the bitter taste to a degree and often involves adding artificial flavours and sweeteners. The pharmacy department at Princess Margaret hospital (PMH) in partnership with the Anaesthesiology, Pharmacology and Pharmacy Unit at the University of Western Australia has developed a novel chocolate sweet which can be used to mask the taste of bitter drugs. It has already been used successfully for other medications and found to be very acceptable to children. Using this delivery system has also given the ability to deliver a smaller defined dose, not previously available in Australia, which will allow easier and more reliable dosing in smaller children. This study plans to test the chocolate tramadol tablet against the current broken-open capsule method of delivering tramadol in patients following minor to moderate operations at Princess Margaret Hospital. We will compare how the new “tablet” is tolerated, absorbed and if it is an effective pain reliever. Ultimately we hope to develop a new method to deliver tramadol so it can be more easily and safely be given to children.