Watch out for overdoses. The independent medical journal Prescribe warning on the risks of overdoses linked to oral tramadol in children. She writes an article on this subject in her May 2021 issue.

The drugs targeted are the two specialties of drinkable tramadol marketed in France: Contramal® and Topalgic® packaged in dropper bottles. These are analgesics from the opioid family, used in the treatment of moderate to severe pain.

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300 mg instead of 20 mg

To illustrate its alert, the review Prescribe reviews the case of an overdose that occurred in France in 2020 in a 10-year-old child. This last one is “admitted to the emergency room for progressive sleepiness since breakfast, abnormally constricted pupils and slow breathingThe child had been prescribed tramadol for trauma-related pain.

But his parents gave him the oral solution “like a syrup“regrets Prescribing,”by pouring drops into a teaspoon“. Result:”the amount received by the child that morning was estimated at 3 ml, or 300 mg of tramadol instead of the 20 mg prescribed (8 drops)“, calculates the review.

0.4 drops per kilogram

An awkwardness “serious“but not uncommon, according to Prescribe. Because we must not confuse drop and milligram which can easily be the case with this medication for children.

Indeed, the dosage is one milligram of tramadol per kilogram of the child. This represents 0.4 drop per kg. If the doctor does not calculate the number of drops himself and does not clearly indicate this to the parents, they should refer to the package leaflet of the medication.

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A complex calculation

They will take into account the weight of the child, will translate it into milligrams of tramadol … which should not then be forgotten to convert into the number of drops. For example, a 20 kg child will need to be given 20 milligrams of tramadol, which is just eight (20×0.4) drops.

Confusion therefore quickly arose between the dose in milligrams and the number of drops, worries Prescribe. Gold “an error of a few drops exposes young children to serious consequences“summarize the specialists.

Decrease drug concentration

How then to limit these risks? For Prescribe, it is up to pharmaceutical laboratories and the French Medicines Agency to act upstream, by replacing the dropper bottles with less concentrated solutions.

These would reduce “the extent of overdoses“and”the volume of the doses would be greater, facilitating the use of oral syringes graduated in milligrams of tramadol, clearly identified, and of a capacity not exceeding the maximum dose per doseThis is particularly the case in the United States, where low concentration oral solutions were authorized in 2020.

Specify the number of drops

Pending these measures, it is essential to “specify both in writing and orally the number of drops to be administered at each dose and to ensure that this is clearly understood and transmitted to those around the child “ notes the journal Prescrire.

A valid advice as soon as “tramadol is chosen despite its dangers and its often uncertain value“, also blows the review, which recalled in 2020 that this molecule”exposes to risks which require the same vigilance as with morphine“.

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