Few opioid analgesics have a presentation as a solution suitable for oral administration as a function of weight in children.
Morphine presented as an oral solution (multi-dose and single-dose vials) can be used in infants from 6 months of age. However, only the multidose presentation (Oramorph 20 mg/1ml) allows doge adjustment according to the weight of the child - all other oral solutions are presented in single dose containers of 10 mg, 30 mg and 100 mg, each for 5 ml of solution. The ANSM met with the laboratory to discuss the provision of single-dose, low dose presentations (1 and 2 mg) more appropriate for paedi-atric use.
After opening, the capsules (Actiskénan immediate release and Skénan prolonged release) can be used in infants from 6 months of age by mixing their contents in food. The microgranules of the Skénan capsules keep their prolonged action properties.
Morphine tablets (Moscontin and Sevredol), for their part, are prohibited in children under 6 years of age due to the risk of false route.
Tramadol is also presented as an oral solution in a dropper bottle (100 mg/ml) with use possible in children from 3 years of age and a dose defined according to weight. In view of the large number of medication errors reported with the dropper bottle, the ANSM asked the laboratory to develop a less concentrated formulation and a presentation with a pipette graded in mg, more suitable for paediatric use.
Buprenorphine, sublingual tablet (Temgesic) and hydromor-phone can be used exceptionally in children 7 to 15 years of age.
Codeine has been contraindicated in children under 12 years of age since 2013.
Regarding the injectable forms, morphine for injection is the only opioid analgesic that can be administered from birth, then pethidine from 6 months, and nalbuphine from 18 months.
Transdermal fentanyl (12 and 25 μg/h) may be administered to children over 2 years of age already receiving a dose equivalent to at least 30 mg morphine orally per day.
Oral form
Morphine Child over 6 months of age for adapted oral forms (oral solution, capsule) Child over 6 years of age for non-adapted oral forms (tablet)
Tramadol From 3 years of age for the oral solution From 12 or 15 years for other oral forms Buprenorphine Contraindicated in children < 7 years
Exceptional use between 7 and 15 years Hydromorphone Contraindicated in children < 7 years
Exceptional use between 7 and 15 years
Codeine From 12 years of age, contraindicated in children < 12 years Dihydrocodeine Contraindicated in children < 15 years
Opium Contraindicated in children < 15 years
Oxycodone Reserved for adults
Tapentadol Reserved for adults
Injectable form
Morphine From birth
Péthidine Contraindicated in children < 6 months
Nalbuphine Data insufficient for children < 18 months of age Buprénorphine Contraindicated in children < 15 years
Tramadol Contraindicated in children < 15 years
Oxycodone Reserved for adults
Other forms
Transdermal fentanyl From 2 years
Opium suppository (Lamaline) Contraindicated in children < 15 years Fast-acting fentanyl Reserved for adults
OPIOID ANALGESICS AUTHORISED FOR USE IN CHILDREN
(see also the Summary of Product Characteristics for each medicinal product on the public pharmaceutical database - http://base-donnees-publique.
medicaments.gouv.fr)
Following reports of death and serious undesirable effects, following tonsilectomy in the majority of cases, codeine has been contraindicated in children under 12 years of age since 2013.
In 2016, the HAS published its recommendations for good practice “Medicinal management of pain in children: an alternative to codeine.” When opioid analgesia is required
in a child under 12 years of age, the molecule of choice in case of severe pain, or in case of failure of less powerful analgesics, is morphine. Low doses should be proposed at the start of treatment (0.1 mg/kg/dose) in children under 1 year of age, and monitoring must be increased. Tramadol may be considered in children over 3 years of age, although its metabolism follows the same route as codeine in part, and serious undesirable effects can occur.
MEDICINAL MANAGEMENT OF PAIN IN CHILDREN: AN ALTERNATIVE TO CODEINE
(Prise en charge médicamenteuse de la douleur chez l’enfant : alternative à la codéine. HAS, JANUARY 2016)
Use and Abuse of Opioid Analgesics - Situation Report -
23
In children, cases of fatal errors of administration have been reported. These errors are essentially related to difficulties in understanding by patients and those in their family/care networks of the dose prescribed by the doctor, potentially leading to significant overdose of tramadol.
In 2016, the ANSM issued a reminder to healthcare professionals of the importance of clear dose instructions, and to parents of the importance of strict compliance with the doctor’s prescription, requesting:
prescribing physicians:
• to write-out the dose in terms of the number of drops per dose, the number of doses per day,
• to inform parents of the need to strictly adhere to the doses prescribed,
• to remind parents of the need to keep this medicine out of the sight and reach of children,
• to inform parents of the signs of overdose, and of the need to consult a doctor or an emergency service immediately in case of appearance of these signs, in particular upon the first administration to the child.
pharmacists:
• to ensure that the prescribed dose is expressed as a number of drops per dose,
• to inform the parents of the need to respect the dose prescribed,
• to write the number of drops to be administered per dose on the box or the bottle,
• to remind parents how a dropper bottle works,
• to inform parents of the need to immediately consult a doctor or an emergency service in case of signs of overdose.
parents:
• to respect the doctor’s prescription,
• to ask the advice of a doctor or a pharmacist if in doubt about the prescription or the operation of the dropper bottle,
• to keep the medication out of the sight and reach of children,
• to consult a doctor or emergency department immediately if signs of overdose (vomiting, disturbances of
consciousness, breathing difficulties etc.) occur.
ORAL TRAMADOL SOLUTION IN CHILDREN: AWARENESS OF MEDICATION ERRORS
(Solution buvable de tramadol chez l’enfant : attention aux erreurs médicamenteuses. ANSM, JUNE 2016)