Unethical pain research in the newborn. A list of shame.

Unethical pain studies are still being published, in journals which include several from mainstream publishing houses.

In these studies published recently and appearing on-line in recent weeks, newborn infants were assigned by the researchers to experience pain. The reviewers of the articles accepted that the research subject babies had pain imposed by the investigstors. The editors of the journals involved are also complicit by agreeing to publish articles whose research required that babies experienced avoidable pain.

This must stop.

It is unacceptable to inflict pain on babies in order to complete a research project.

Please inform the editorial board of the following journals of your concerns. The chief editor’s professional email is provided, or an email address associated with the publication if I can find one.

I will repost this page with new articles whenever I spot them.

The Effect of Maternal Voice on Venipuncture Induced Pain in Neonates: A Randomized Study. Chen Y, Li Y, Sun J, Han D, Feng S, Zhang X. Pain Manag Nurs. 2021 Oct;22(5):668-673. doi: 10.1016/j.pmn.2021.01.002. Epub 2021 Mar 2. PMID: 33674242. The trial randomized 58 babies undergoing venepuncture to have a recording of their mother’s voice, or to have the painful procedure without analgesia. Editor-in-Chief: Dr Elaine Miller, MILLEREL@ucmail.uc.edu

Effect of White Noise and Lullabies on Pain and Vital Signs in Invasive Interventions Applied to Premature Babies. Döra Ö, Büyük ET. Pain Manag Nurs. 2021 Dec;22(6):724-729. doi: 10.1016/j.pmn.2021.05.005. Epub 2021 Jun 28. PMID: 34210600. In this trial 66 babies (which was either randomized, according to the text, or non-randomized, according to the figure) were assigned to either have a lullaby, or white noise, or to have no intervention, prior to the pain of a “blood collection” (not further specified). Editor-in-Chief: of Pain Management Nursing, Dr Elaine Miller, MILLEREL@ucmail.uc.edu

Gao H, Xu G, Li F, Lv H, Rong H, Mi Y, Li M. Effect of combined pharmacological, behavioral, and physical interventions for procedural pain on salivary cortisol and neurobehavioral development in preterm infants: a randomized controlled trial. Pain. 2021 Jan;162(1):253-262. doi: 10.1097/j.pain.0000000000002015. PMID: 32773596. In this trial, 38 preterm infants were randomized within 7 2hours of birth to have all of their painful procedures during hospitalisation untreated, they were allowed to get a soother when they cried! In the combined interventions group, preterm infants received sucrose, massage, music, non-nutritive sucking, and gentle human touch. I think this is the worst of all the trials I have seen recently, the control babies had repeated evaluations of PIPP score during painful procedures, and continued to have multiple experiences of moderate to severe pain, with average PIPP scores of over 12. How can the reviewers and editors possibly have thought this was OK? Editor-in-Chief: Dr Francis Keefe keefe003@mc.duke.edu

Here is some suggested text you can cut and paste into an email if you wish.

The article “XXXXX” published in your journal, describes research which is clearly unethical and should not have been published.
In this study, newborn babies were assigned to a group designed to experience pain. Effective methods to prevent pain caused by skin breaking procedures are well known, easily available, and cheap or free. Those methods include kangaroo care/skin-to-skin contact, oral sucrose or glucose solutions, especially when combined with non-nutritive sucking, and breastfeeding. There is no valid reason for denying such pain reduction methods to research subjects. Publication in a high-quality journal such as the one you edit gives credibility to the research and suggests that it is acceptable to inflict pain on babies in order to complete a research project.
Research which compares an analgesic intervention for a painful procedure in newborn infants to an untreated control group is useless in improving care. As effective pain measures are already well known, the only research which could possibly improve care is that which compares different analgesic interventions, or examines the addition of measures to those already known to be effective.
The most effective way your journal could improve pain control in newborn infants would be to cease publishing research which unethically randomizes babies to have avoidable pain. All future trials in newborn infants undergoing planned painful procedures that the journal publishes should ensure that research subjects in all groups receive proven effective methods of pain control.
I urge you to retract this article and to establish editorial standards which prohibit the publication of research in which avoidable pain is imposed on newborn infants. Pain inflicted on babies in order to perform research should be an immediate criterion for rejection of a manuscript.

About Keith Barrington

I am a neonatologist and clinical researcher at Sainte Justine University Health Center in Montréal
This entry was posted in Neonatal Research and tagged , , , . Bookmark the permalink.

2 Responses to Unethical pain research in the newborn. A list of shame.

  1. Jose Diaz-Rossello says:

    Dear Dr Barrington I forwarded your comments to the main authors of the three papers In case a get their response I will forward it to you

    Best regards

  2. Honorio Sanchez Zaplana says:

    I’ve sent too three mail to the editors. Thanks Dr. Barrington. It’s a shame
    Dr. Honorio Sánchez Zaplana. Neonatologist. Alicante. Spain.

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