The World Health Organization (WHO) has issued a new guidance, Guidelines on the Management of Chronic Pain in Children, which recommends physical, psychological, and pharmacological interventions for pain relief in children aged 0-19 years. Available here.
Our readers may remember that in 2019, the WHO withdrew the two guidelines Ensuring Balance in National Policies on Controlled Substances and Guidelines on the Pharmacological Treatment of Persisting Pain in Children with Medical Illnesses. (You can read some of the background on this and the Joint Response by the civil society organizations here.) The new guidelines for children replace the previous one, while the Ensuring Balance Guideline mentioned in the Joint Response has yet to be updated and published.
First of all, we are glad that the WHO has completed and finalized publication of the children’s pain guidance. We hope that the WHO will continue working diligently to complete the Ensuring Balance Guidelines to fill in the void left by its withdrawal. This action has had a negative effect on ensuring access to appropriate treatment and care for patients in pain and those with palliative care needs.
We are also glad that the children’s pain guidelines clearly state that access to pain management is a fundamental human right. It is the first time WHO has stated this so clearly.
In spite of this, there are several issues that we find troublesome. Although the Guidelines underscore the need to implement a multimodal approach to pain management, spiritual care is not mentioned at all. This is a major omission and a failure to recognize all human dimensions to ensure a holistic approach to appropriate care, and thus, we expect that spiritual care experts will address this void and the implications of this omission in their reviews and statements.
On the field in which we have more expertise, we are deeply concerned about the strong focus on prevention of “abuse” of opioids, and the text’s repeated highlighting a model called “opioid stewardship.” Although the guideline opens by describing its strictly evidence-based methodology, the final section mentions that research on the harm risk of opioid treatment in children is completely lacking.
We think the first three recommendations in the Guidelines do not provide clear guidance, while the fourth is somewhat more useful. However, we find the narrower text of recommendation 4b worrying: “...in specific and limited situations for children with life-limiting conditions.” We are afraid that government regulators and legislators may interpret this very narrowly and that many children will be cut off from access if their situation is not specific and sufficiently limited. Moreover, although some statements mention the need to balance concerns about access to opioids with fears of diversion and misuse, the strong emphasis is on this model of “opioid stewardship” that is focused on the prevention of non-medical use. There is not a single mention of the principle of balance which has been a key concept in our efforts to ensure availability for the rational use of opioids for legitimate medical needs.
The limitations and flaws of the new pediatric pain guidelines is multi-factorial. The first factor is an issue of diplomacy. Probably in an effort to avoid any criticism from a member state and avoid a situation similar to the one WHO faced in 2019, the Secretariat convened a group of individuals for the working group that included persons focused on opioid misuse and dependence syndrome, while excluding key individuals and leading experts on pediatric pain and advocacy who were involved in the development of the first guideline. This resulted in a mix of persons who may not represent those with the greatest amount of expertise and knowledge in pediatric pain needed to develop WHO guidelines.
The second factor is the effort to create a generic guideline for all types of pain. There is a world of difference between children with migraine or other headaches, children with life-threatening illnesses such as mucoviscidosis, and children with cancer. We are more concerned about misuse of NSAIDs or other analgesics for headache and its long-term sequelae than about opioid misuse in children and adolescents. Dealing with chronic pain in children without further differentiation seems difficult. We are concerned that “opiophobia” has prevailed in the published guidance.
The third factor is that, according to WHO’s guidance on the development of guidelines, the recommendations have to be based on robust evidence. As all our palliative care colleagues are aware, the level of evidence available in the literature on the efficacy, effectiveness, and safety of medications and therapeutic interventions for pain and palliative care is extremely limited. There are valid, ethical concerns about using randomized, blind, controlled trials in palliative care, especially when palliative care focuses on the relief of serious health-related suffering, which should be mitigated as fast as possible.
One way to resolve some of these limitations for future clinical guidelines would be to separate them into recommendations for the management of acute, cancer, and chronic non-cancer pain. And, of course, to ensure that the individuals who are selected to participate in the working group are experts in the field and of topics covered in each.
Until next month,
Lukas Radbruch, MD
Chair Board of Directors
Liliana De Lima, MHA
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