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Premedication with melatonin vs midazolam: efficacy on anxiety and compliance in paediatric surgical patients

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Abstract

Preoperative anxiety is a major problem in paediatric surgical patients. Melatonin has been used as a premedicant agent and data regarding effectiveness are controversial. The primary outcome of this randomized clinical trial was to evaluate the effectiveness of oral melatonin premedication, in comparison to midazolam, in reducing preoperative anxiety in children undergoing elective surgery. As secondary outcome, compliance to intravenous induction anaesthesia was assessed. There were 80 children undergoing surgery randomly assigned, 40 per group, to receive oral midazolam (0.5 mg/kg, max 20 mg) or oral melatonin (0.5 mg/kg, max 20 mg). Trait anxiety of children and their mothers (State-Trait Anxiety Inventory) at admission, preoperative anxiety and during anaesthesia induction (Modified Yale Pre-operative Anxiety Scale), and children’s compliance with anaesthesia induction (Induction Compliance Checklist) were all assessed. Children premedicated with melatonin and midazolam did not show significant differences in preoperative anxiety levels, either in the preoperative room or during anaesthesia induction. Moreover, compliance during anaesthesia induction was similar in both groups.

Conclusions: This study adds new encouraging data, further supporting the potential use of melatonin premedication in reducing anxiety and improving compliance to induction of anaesthesia in children undergoing surgery. Nevertheless, further larger controlled clinical trials are needed to confirm the real effectiveness of melatonin as a premedicant agent in paediatric population.

What is Known:

• Although midazolam represents the preferred treatment as a premedication for children before induction of anaesthesia, it has several side effects.

• Melatonin has been successfully used as a premedicant agent in adults, while data regarding effectiveness in children are controversial.

What is New:

• In this study, melatonin was as effective as midazolam in reducing children’s anxiety in both preoperative room and at induction of anaesthesia.

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Abbreviations

ICC:

Induction Compliance Checklist

IQR:

Interquantile ranges

m-YPAS:

Modified Yale Pre-operative Anxiety Scale

OS:

Oxidative stress

STAI:

State-Trait Anxiety Inventory

STAI-C:

State-Trait Anxiety Inventory for Children

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Author information

Authors and Affiliations

  1. Unit of Pediatric Surgery, University of Messina, Messina, Italy

    Pietro Impellizzeri, Tiziana Russo, Maria Rosaria Gravina, Salvatore Arena & Angela Simona Montalto

  2. Department of Psychology, University of Messina, Messina, Italy

    Enrica Vinci, Maria Cristina Gugliandolo, Francesca Cuzzocrea, Rosalba Larcan & Carmelo Romeo

  3. Department of Paediatrics, Neonatal and Pediatric Intensive Care Unit, University of Messina, Via Consolare Valeria, 1, 98125, Messina, Italy

    Gabriella D’Angelo, Eloisa Gitto & Lucia Marseglia

  4. Department of Economics, University of Messina, Messina, Italy

    Angela Alibrandi

Authors
  1. Pietro Impellizzeri
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  2. Enrica Vinci
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  4. Francesca Cuzzocrea
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  9. Gabriella D’Angelo
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  10. Eloisa Gitto
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  11. Angela Simona Montalto
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  12. Angela Alibrandi
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  13. Lucia Marseglia
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  14. Carmelo Romeo
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Contributions

Carmelo and Romeo Eloisa Gitto designed the study; Francesca Cuzzocrea, Rosalba Larcan, Tiziana Russo, and Maria Rosaria Gravina developed the methodology; Enrica Vinci, Maria Cristina Gugliandolo, and Angela Simona Montalto collected the data; Gabriella D’Angelo, Salvatore Arena, and Angela Alibrandi performed the analysis; and Lucia Marseglia and Pietro Impellizzeri wrote the manuscript.

Corresponding author

Correspondence to Lucia Marseglia.

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Conflict of interest

The authors declare that they have no conflict of interest.

Statement of financial support

Prof Carmelo Romeo received 2513.70 euros as grant for a university research project (University of Messina) to support this study. All other authors declare that they did not receive any financial support for this research.

Ethical approval

All procedures performed in this study were in accordance with the ethical standards of the institutional and national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the study.

Additional information

Communicated by Jaan Toelen

Revisions received: 10 January 2017 / 20 April 2017 / 11 May 2017

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Impellizzeri, P., Vinci, E., Gugliandolo, M.C. et al. Premedication with melatonin vs midazolam: efficacy on anxiety and compliance in paediatric surgical patients. Eur J Pediatr 176, 947–953 (2017). https://doi.org/10.1007/s00431-017-2933-9

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  • DOI: https://doi.org/10.1007/s00431-017-2933-9

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