Clinical trial NCT03878173: Evaluation of Post-operative Discomforts in Children After Extraction of Temporary Teeth
Official title: Evaluation of Post-operative Discomforts in Children After Extraction of Temporary Teeth _ DEXTRAFANT _ RC16_0183
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-extraction Pain (PEP)
Post-extraction Lip or Cheek Biting Injury (PEBI)
Post-extraction Bleeding (PEB)
Tooth Removal
Keywords: temporary tooth
pain
analgesic
paracetamol
acetaminophen
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2019-03-18
Enrollment: 125
Sex: ALL
Minimum age (years): 2
Maximum age (years): 15
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 125 children in range of 2-15 years indicated for tooth extractions will be included in this study.

Brief summary: This prospective observational study aim to evaluate discomforts after extraction of temporary tooth under local anesthesia. The first objective is to describe the prevalence of the post-extraction pain (PEP), post-extraction bleeding (PEB), post-extraction biting injury (PEBI) in children, and the analgesic usage. The secondary objective is to define whether it is possible to determine a profile of patients or a type of extraction's procedure predictive to PEP and administration of analgesics, PEB or PEBI.

Detailed description: 125 children in range of 2-15 years indicated for tooth extractions will be included in this study.

Informed consent will be obtained from all individual participants included in this study.

Immediately after extraction and until the following day, parents will be asked to assess the post-operative discomforts and to administrate paracetamol (acetaminophen) as soon as the child expressed a pain score ≥2 evaluated on the faces pain scale-revised (FPS-R).

A structured form is designed to obtained information regarding the patient's age, gender, socioeconomic level, and cooperation of the child before and during anesthesia or extraction, influence of accompanying person, number of previous extraction, dental hygiene. Moreover, details about the type of extraction; the indication of extraction (tooth decay, orthodontic treatment, obstacle, infection and traumatism), the type of tooth (incisor-canine or molar), the degree of root resorption, number of doses of local anesthetic, and presence of preexisting or per-operative pain are also collected.

Eligibility criteria: Inclusion Criteria:

* children in range of 2-15 years indicated for tooth extractions under local anesthesia.

Exclusion Criteria:

* patient under analgesic the day of the appointment or under non steroidal anti-inflammatory agents through 8 days before the extraction;
* contraindication to paracetamol/acetaminophen;
* incomplete mental health;
* extraction under sedation (including nitrous oxide/oxygen) and under general anesthesia.
* extractions of permanent tooth;

Child was also excluded from the study if parents could not be reached by phone within 32 hours after extraction and if the parents don't speak French.

Primary outcomes:
measure: prevalence and severity of pain after extraction of deciduous teeth
timeFrame: 32 hours post-operatively
Secondary outcomes:
measure: Determination of a profile of patients predictive to PEP and administration of analgesics, PEB or PEBI
timeFrame: Day 1
measure: Determination of a profile of a type of extraction's procedure predictive to PEP and administration of analgesics, PEB or PEBI
timeFrame: Day 1
Other outcomes:
Locations:
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes
Study officials:
affiliation: Nantes University Hospital
name: Brigitte Alliot-Licht, Dr
role: PRINCIPAL_INVESTIGATOR
References: