Study authors urge IRBs to reject trials that deny babies pain relief

By Gareth Macdonald contact

- Last updated on GMT

IRBs urged to reject trials that deny babies pain relief
IRBs urged to reject trials that deny babies pain relief
Researchers are urging review boards to reject neonatal clinical trials if protocols require that babies in control groups are denied analgesia.

The call follows the publication of a study in Acta Pediatrica​ which revealed that babies in control groups either received no pain relief or were given placebos in 32 of the 46 trials included in the review, which runs contrary to guidelines​ stating they should be spared from avoidable pain.

Co-author Carlo Bellieni, from the University of Siena’s neonatal intensive care unit, told Outsourcing-pharma.com studies included in the review revolved around routine testing procedures like venipunctures or heel-pricks for which pain relief techniques are available.

Nonpharmacological analgesic treatments exist for these minor procedures and are routinely used in almost all neonatology departments​” he said, adding that “Dr Johnston and I believe that babies enrolled as controls in studies for new treatments should receive these validated analgesic treatments.”

He admitted that adding pain relief to studies in neonates would introduced a layer of complexity

We are aware it [providing pain relief to control group babies] is not so easy, because comparing new treatments with babies who receive analgesia requires much more babies and time and this sometimes makes new studies almost impossible​.”

Nevertheless Bellieni and colleague Celeste Johnson, Associate Director for Research at the McGill School of Nursing in Canada, say pain relief should be provided.

The urged ethical committees and institutional review board (IRB) to refuse clinical trials that expose babies to unnecessary pain and called on science journals to refuse to publish them.  

Source Acta Pediatrica

Title "Analgesia, nil or placebo to babies, in trials that test new analgesic treatments for procedural pain"

Carlo V Bellieni and C Celeste Johnston

DOI: 10.1111/apa.13210

Related news

Show more

Related products

show more

Using SDTM, ADaM, and SEND

Using SDTM, ADaM, and SEND

Formedix | 09-Nov-2022 | Technical / White Paper

This article gives an overview of SDTM, ADaM, SEND and ARM, and discusses how these CDISC standards fit in with the wider clinical trial process, and how...

How to design an effective CRF

How to design an effective CRF

Formedix | 10-Oct-2022 | Technical / White Paper

CRFs and eCRFs are used for gathering patient data during clinical trials. They play a crucial role in helping to assess the safety and efficacy of clinical...

The Complexities of Ophthalmic Drug Development

The Complexities of Ophthalmic Drug Development

Altasciences | 04-Oct-2022 | Technical / White Paper

Ophthalmic drug development comes with a unique set of challenges that can be mitigated by working with an end-to-end solution provider with regulatory...

Related suppliers

Follow us

Products

View more

Webinars