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Electrophysiological Measurements and Analysis of Nociception in Human Infants
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Pain-relieving agents for infantile colic.

Elena Biagioli1, Valentina Tarasco, Carla Lingua

  • 1Laboratory Methodology for Clinical Research, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Via La Masa, 19, Milan, Italy.

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Evidence for pain-relieving agents in infantile colic is limited and biased. Most studies had small sample sizes and serious limitations, with inconsistent reported benefits. Further research is needed.

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Area of Science:

  • Pediatrics
  • Pharmacology
  • Evidence-Based Medicine

Background:

  • Infantile colic affects 4-28% of infants globally, presenting a common parental concern.
  • While self-limiting, colic prompts parental action, leading to the exploration of pain-relieving agents.
  • Interventions like drugs, sugars, and herbal remedies are investigated to reduce crying episodes.

Purpose of the Study:

  • To evaluate the efficacy and safety of pain-relieving agents for infantile colic in infants under four months.
  • To synthesize evidence from randomized controlled trials (RCTs) on colic treatments.

Main Methods:

  • Comprehensive database searches (CENTRAL, MEDLINE, Embase, PsycINFO) conducted in March 2015 and May 2016.
  • Inclusion of randomized controlled trials (RCTs) and quasi-RCTs assessing pain-relieving agents for infantile colic.
  • Adherence to Cochrane Collaboration's standard methodological procedures for data collection and analysis.

Main Results:

  • Eighteen RCTs involving 1014 infants were included; all were small and at high risk of bias.
  • Simethicone showed no significant difference compared to placebo or herbal agents.
  • Herbal agents demonstrated low-quality evidence for reduced crying duration and moderate-quality evidence for increased response.
  • Sucrose showed very low-quality evidence for reduced crying time.
  • Dicyclomine and cimetropium bromide showed some positive effects in single studies but had associated adverse events (dicyclomine) or very low-quality evidence.
  • No serious adverse events were reported except for dicyclomine.

Conclusions:

  • Current evidence on the effectiveness of pain-relieving agents for infantile colic is sparse, prone to bias, and limited by small sample sizes.
  • No definitive evidence supports the use of simethicone; herbal agents, sugar, dicyclomine, and cimetropium bromide are not consistently recommended due to limited or low-quality evidence and potential side effects.
  • There is a critical need for high-quality RCTs with standardized measures and blinded participants to reliably compare interventions.