Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07718477

Compare the Intensity of Pain Felt by Children During the Local Anesthesia Procedure to That Perceived by the Accompanying Parent.

The goal of this observational study is to compare the intensity of pain experienced by children (aged 6 to 15) during local anaesthesia with that perceived by the parent accompanying them. The main question it aims to answer is:

Can a parent help assess their child's pain when the child is unable to assess it themselves? A preliminary study carried out in the dentistry department of Clermont-Ferrand University Hospital in 2019 showed that parents could be effective external assessors in distinguishing between pain and anxiety in their own children, whom they know well, and were better at this than dentists, who are more prone to errors of judgement.13 This pilot study covered several dental procedures, including pulpotomy, extraction of a primary tooth, curettage of a carious lesion and dental anaesthesia. The study yielded interesting results but also contained some biases, so the investigators would like to improve upon it. To do so, the focus here is on a single therapeutic procedure: local anaesthesia, which is one of the procedures most feared by children and, very often, by the parents accompanying them as well.

Once consent has been obtained from both parents (or legal guardians), two questionnaires will be used. The first will consist of simple questions and will be aimed at the children (9 items). The second (20 items) will be for parents and will provide additional information on the child's state of health and on the parents' anxiety regarding their own dental care and that provided to their child. The main aim of both questionnaires will be to assess the intensity of pain perceived by the child during the administration of local anaesthesia, with the child self-reporting their pain and the parent providing an external assessment. These questionnaires will be completed every Wednesday, which allows a child (requiring multiple treatments) to complete the questionnaires several times, thereby enabling us to observe changes in the pain perceived by the child and their accompanying parent over the course of successive anaesthetic procedures.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

6 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, France

Location contact

Anne MISHELLANY-DUTOUR

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children aged 6 to 15
  • Children requiring dental treatment involving local anaesthetic
  • Children accompanied by at least one parent (or legal guardian)
  • Children and parents who speak French fluently

Exclusion criteria

  • Children under the age of 6 (complex self-assessment)
  • Children over the age of 15 (no longer fall within the scope of paediatric dentistry)
  • Children or accompanying parents who have difficulty understanding due to a limited command of French or any form of intellectual disability
  • Children whose parents have not consented to their participation in the study
  • Children who do not wish to participate in the study
  • Unaccompanied children
  • Children with an intolerance or allergy to local anaesthetics, vasoconstrictors or excipients

Treatment and study plan

Primary outcomes

  1. Assessment of pain (Numerical Rating Scale: NRS) as reported by the child and as perceived by the parent

    Time frame: Day 1

    Pain intensity assessed using a 0-10 Numerical Rating Scale (NRS), as self-reported by the child and independently rated by the parent according to their perception of the child's pain.

Secondary outcomes

  1. Assessment of anxiety in children and parents regarding dental anaesthesia (Numerical Rating Scale: NRS)

    Time frame: Day 1

    Anxiety related to dental anaesthesia assessed using a 0-10 Numerical Rating Scale (NRS), as self-reported by the child and independently self-reported by the parent.

  2. To investigate the correlation between 2 measurements: anxiety (Numerical Rating Scale: NRS) about dental treatment and the assessment of pain intensity (Numerical Rating Scale: NRS)

    Time frame: Day 1

    Association between anxiety related to dental treatment and pain intensity, both assessed using a 0-10 Numerical Rating Scale (NRS). Correlation analysis will be performed to evaluate the relationship between these two measures reported by the children and their accompanying parents (or legal guardians), depending on normality of data, correlation will be assessed using Pearson or Spearman coefficient

  3. Create a categorical score for children with multiple medical conditions and pain during anaesthesia

    Time frame: Day 1

    The medical score will equal the weighted sum of medical conditions (0 = absence, 1 moderate, 2 severe for each condition), and that score will be correlated with pain score using either Pearson or Spearman coefficient depending on normality of data

  4. To investigate the correlation between 2 measurements: pre-operative pain history (Numerical Rating Scale: NRS) and the assessment of pain intensity (Numerical Rating Scale: NRS)

    Time frame: Day 1

    The association between pre-operative pain history and pain intensity during dental anaesthesia will be evaluated. Pre-operative pain history and pain intensity will both be assessed using a 0-10 Numerical Rating Scale (NRS). Correlation analysis will be performed to evaluate the relationship between these two measures, depending on normality of data, correlation will be assessed using Pearson or Spearman coefficient

  5. Monitor changes in pain intensity from the first anaesthetic administration to the last, should the patient return for treatment (Numerical Rating Scale: NRS)

    Time frame: Day 1

    Changes in pain intensity will be assessed using a 0-10 Numerical Rating Scale (NRS) by comparing pain scores reported during the first dental anaesthesia session with those reported during the last anaesthesia session in children who return for subsequent treatment, by using either a pearson/spearman correlation or an Intra Class correlation, similarly to a test-retest assessement.

Study contacts

Contact information is provided by the study sponsor or research team.

Lise Laclautre

CONTACT

[email protected]

0473754963

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France
  • Laboratory NeuroDol U1107 Inserm
  • University Clermont Auvergne (UCA), Clermont-Ferrand, France

Registry information

Acronym: ADDenT

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 22, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.