Evaluation of Post-operative Discomforts in Children After Extraction of Temporary Teeth

NCT03878173 | Completed

• 1 other identifier: RC16_0183
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• prevalence and severity of pain after extraction of deciduous teeth

  pain evaluated on the EVA faces pain scale-revised

  32 hours post-operatively

Secondary Outcomes (2)

• Determination of a profile of patients predictive to PEP and administration of analgesics, PEB or PEBI

  Day 1

• Determination of a profile of a type of extraction's procedure predictive to PEP and administration of analgesics, PEB or PEBI

  Day 1

Interventions

No intervention OTHER

No intervention

Eligibility Criteria

• Age: 2 Years - 15 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Centre Hospitalier Universitaire de Nantes

Nantes, 44093, France

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Brigitte Alliot-Licht, Dr

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 18, 2019
• Study Start: April 1, 2016
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: March 19, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)