News Release

Many babies in clinical trials experience unnecessary pain

Peer-Reviewed Publication


A recent review found that most newborns that are included in control groups during clinical trials concerning minor painful procedures are denied analgesia, despite international guidelines stating that babies should be prevented from experiencing any avoidable pain.

Investigators found 46 studies in the 30 months up to June 2015 and found that in 32 (70%) the "control" babies received either placebos or no pain treatment. Placebos were used in 16/25 (64%) studies involving heel pricks and in 6/7 (85%) involving vein punctures.

The researchers urge ethical committees to refuse clinical trials that expose babies to unnecessary pain, and journals to refuse to publish them.

"The progress of neonatal analgesia accounted for this behavior. Now is the moment for a reflection: even minor procedures can induce pain, and every avoidable pain is unjust," said Dr. Carlo Bellieni, lead author of the Acta Paediatrica review.


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