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[Does the placebo effect exist in newborn infants?]

P Barbier1, C Lionnet, A P Jonville

  • 1Service de Pharmacologie Clinique, Hôpital Bretonneau, Tours.

Therapie
|March 1, 1994
PubMed
Summary
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Neonatologists often avoid placebos due to a perceived lack of placebo effect in infants. This study found no difference in pain responses between neonates receiving no treatment and those given sucrose water, challenging this assumption.

Area of Science:

  • Neonatal pain research
  • Pediatric pharmacology
  • Clinical trial methodology

Background:

  • Placebo-controlled trials are essential for drug efficacy assessment.
  • Neonatologists express reluctance to use placebos in neonates, citing a lack of placebo effect.

Purpose of the Study:

  • To investigate the presence of a placebo effect in neonates during a painful procedure.
  • To evaluate the efficacy of sucrose as a placebo intervention for neonatal pain.

Main Methods:

  • Open-label, randomized study design.
  • Comparison of no treatment versus "analgesic" treatment (water and sucrose).
  • Measurement of heart rate, respiration rate, and behavioral responses during heelstick for phenylketonuria screening.

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Main Results:

  • No significant differences were observed in heart rate, respiration rate, or behavioral indicators of pain between the no-treatment and sucrose groups.
  • The study did not demonstrate a discernible placebo effect in neonates under the tested conditions.

Conclusions:

  • The findings challenge the notion that neonates lack a placebo effect.
  • Methodological limitations in pain assessment tools may influence the detection of placebo effects.
  • Results suggest that placebo use should be reconsidered in pediatric drug evaluation trials.