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

Acta Paediatr. 2016 Feb;105(2):129-36. doi: 10.1111/apa.13210. Epub 2015 Oct 30.


This review assessed how often neonates in control groups experienced unnecessary pain during clinical trials involving procedural pain. We retrieved 45 studies in the 30 months up to June 2015 and found that in 29 (64%) the control babies received either placebos or no treatment. Placebos were used in 15/25 (60%) studies involving heel pricks and in 6/8 (75%) involving venepuncture.

Conclusion: Despite international guidelines, neonates included in control groups during painful procedures do not receive analgesia in the majority of cases. Several historical reasons can explain this, but in the light of present knowledge, this should not continue. Ethical committees are thereof invited since now to not permit clinical trials that do not explicitly rule out pain during treatments and journals are invited to not publish them.

Keywords: Analgesia; Newborn infants; Placebo; Procedural pain; Randomised controlled trial.

Publication types

  • Review

MeSH terms

  • Analgesia*
  • Blood Specimen Collection / methods
  • Ethics, Medical*
  • Heel
  • Humans
  • Infant, Newborn
  • Pain
  • Phlebotomy