Evidence map›Paper›PMID 28540436›Full record

Trial reportEuropean journal of pediatrics2017

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

Pietro Impellizzeri, Enrica Vinci, Maria Cristina Gugliandolo, Francesca Cuzzocrea, Rosalba Larcan, Tiziana Russo, Maria Rosaria Gravina, Salvatore Arena, Gabriella D'Angelo, Eloisa Gitto and 4 more

Abstract readComparative StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in European journal of pediatrics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 2 pooled it
7.3field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 2 syntheses or guidelines pooled it, 53 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Melatonin as a Potential Approach to Anxiety Treatment.International journal of molecular sciences · 2022
    Review
  11. Review
  12. Article
  13. Article
  14. Review
  15. Review
  16. Review
  17. Melatonin and Comorbidities in Children with Autism Spectrum Disorder.Current developmental disorders reports · 2018
    Review
  18. Procedural pain management in neonates: A Narrative review.International journal of critical illness and injury science
    Review
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 1 institution in 1 country.

Pietro ImpellizzeriUnit of Pediatric Surgery, University of Messina, Messina, Italy.
Enrica VinciDepartment of Psychology, University of Messina, Messina, Italy.
Maria Cristina GugliandoloDepartment of Psychology, University of Messina, Messina, Italy.
Francesca CuzzocreaDepartment of Psychology, University of Messina, Messina, Italy.
Rosalba LarcanDepartment of Psychology, University of Messina, Messina, Italy.
Tiziana RussoUnit of Pediatric Surgery, University of Messina, Messina, Italy.
Maria Rosaria GravinaUnit of Pediatric Surgery, University of Messina, Messina, Italy.
Salvatore ArenaUnit of Pediatric Surgery, University of Messina, Messina, Italy.
Gabriella D'AngeloDepartment of Paediatrics, Neonatal and Pediatric Intensive Care Unit, University of Messina, Via Consolare Valeria, 1, 98125, Messina, Italy.
Eloisa GittoDepartment of Paediatrics, Neonatal and Pediatric Intensive Care Unit, University of Messina, Via Consolare Valeria, 1, 98125, Messina, Italy.
Angela Simona MontaltoUnit of Pediatric Surgery, University of Messina, Messina, Italy.
Angela AlibrandiDepartment of Economics, University of Messina, Messina, Italy.
Lucia MarsegliaDepartment of Paediatrics, Neonatal and Pediatric Intensive Care Unit, University of Messina, Via Consolare Valeria, 1, 98125, Messina, Italy. lmarseglia@unime.it.ORCID http://orcid.org/0000-0003-0720-9387
Carmelo RomeoDepartment of Psychology, University of Messina, Messina, Italy.
University of Messina · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

conclusionsThis 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.

Indexed as

Administration, OralAdolescentAnesthesia, IntravenousAnti-Anxiety AgentsAnxietyChildDouble-Blind MethodDrug Administration ScheduleFemaleHumansMaleMelatoninMidazolamPatient CompliancePremedicationPreoperative CareAnti-Anxiety AgentsMelatoninMidazolamAnaesthesiaAnxiolysisInductionMelatoninMidazolamPreoperative anxiety

Identifiers

PMID28540436
OpenAlexW2617392263

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.