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Vibration-based mitigation of noxious-evoked responses to skin puncture in neonates and infants: a randomised controlled trial
  1. Lance M. Relland1,
  2. Caitlin P. Kjeldsen2,3,
  3. Arnaud Jeanvoine4,
  4. Lelia Emery5,
  5. Kathleen Adderley4,
  6. Rachelle Srinivas4,
  7. Maeve McLoughlin6,
  8. Nathalie L. Maitre2,3
  1. 1 Department of Anesthesiology, Nationwide Children's Hospital, Columbus, Ohio, USA
  2. 2 Department of Pediatrics, Emory University School of Medicine, Atlanta, Georgia, USA
  3. 3 Children's Healthcare of Atlanta Inc, Atlanta, Georgia, USA
  4. 4 Abigail Wexner Research Institute, Nationwide Children's Hospital, Columbus, Ohio, USA
  5. 5 Division of Neonatology, Nationwide Children's Hospital, Columbus, Ohio, USA
  6. 6 The Ohio State University Wexner Medical Center, Columbus, Ohio, USA
  1. Correspondence to Dr. Nathalie L. Maitre, Department of Pediatrics, Emory University School of Medicine, Atlanta, GA 30306, USA; nathalie.linda.maitre{at}emory.edu

Abstract

Objective To assess the effect of a non-noxious vibratory stimulus on noxious-evoked cortical responses to skin puncture and to determine whether the presence of certain behavioural components may be used to predict such cortical responses.

Design Randomised controlled trial.

Setting Level IV neonatal intensive care unit at a stand-alone children’s hospital.

Patients 134 hospitalised infants between 36 and 52 weeks’ postmenstrual age and ordered to receive a clinically required laboratory draw.

Interventions Infants randomised to receive the intervention, a vibratory stimulus at the site of skin puncture beginning 10 s prior to a heel stick, or the control, no vibration.

Main outcome measures Electroencephalography and video recording time-locked to the deployment of the lancet for the skin puncture. Noxious-evoked cortical responses were measured by the area under the curve in the somatosensory region contralateral to the skin puncture. Behavioural responses were coded through video analysis.

Results Noxious-evoked cortical responses were significantly reduced in participants receiving the vibratory stimulus compared with the control (frontal, p<0.0001; central, p=0.0088; central-parietal, p=0.0111). There were no significant differences in behavioural responses between groups (all p>0.05).

Conclusions A non-noxious vibratory stimulus presented prior to and continuing simultaneously with skin puncture significantly mitigates nociception in hospitalised infants. The presence or absence of facial expression components is inadequate to reliably predict pain signalling in the brain.

Trial registration number NCT04050384.

  • Intensive Care Units, Neonatal
  • Neonatology
  • Pain

Data availability statement

Data are available upon reasonable request. Data available on request to corresponding author due to privacy restrictions.

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Data availability statement

Data are available upon reasonable request. Data available on request to corresponding author due to privacy restrictions.

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Footnotes

  • Contributors LMR was the principal investigator and as guarantor, accepts full responsibility for the conduct of the study, had access to the data, and controlled the decision to publish. LMR and NLM were responsible for conceptualisation, methodology and analysis as well as writing for all versions of the manuscript. CPK assisted with data collection, curation and writing. AJ was responsible for data processing and statistical analysis. LE, KA, RS, and MML assisted with data collection and curation.

  • Funding This work was supported by the Society for Pediatric Anesthesia Young Investigator Award awarded to LMR. NLM and CPK are supported by NIH-5R01HD093706-02 outside the submitted work.

  • Competing interests NM holds equity in Thrive Neuromedical. CPK was previously a consultant for Thrive Neuromedical. The remaining authors declare no competing interests.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.