Centre Hospitalier Universitaire de Nantes
Nantes, 44093, France
NCT Number: NCT03878173
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.
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Notify Me2 year–15 year
All sexes
Observational
Nantes, 44093, France
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
No intervention
Time frame: 32 hours post-operatively
pain evaluated on the EVA faces pain scale-revised
Time frame: Day 1
% of patient's by class of: 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.
Time frame: Day 1
% of patient's by class of: 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 immediately after the tooth extraction.
Nantes University Hospital
Other
Evaluation of Post-operative Discomforts in Children After Extraction of Temporary Teeth _ DEXTRAFANT _ RC16_0183
Acronym: DEXTRAFANT
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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.
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