Study of the comfort of children during and after the extraction of milk teeth

Trans and postoperative pain in children submitted to primary molar extraction

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

REBEC

Registry ID

RBR-93djd9

Enrollment

Unknown

Registered

2019-06-04

Start date

2018-12-01

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain Measurement

Interventions

Experimental group G1: 21 children between 5 and 9 years of age with need for extraction of a deciduous molar will receive preoperative analgesia with ibuprofen 100 mg / ml according to their weight p

D27.505.696.663.850.014

E03.155.086.231

E06.892

Eligibility

Age

4 Years to 9 Years

Inclusion criteria

Inclusion criteria: Children aged 4-9 years old that have clinical and radiographic indication of extraction of one erupted primary molar and who agree to participate in the research will be selected. To be included children should present good health and cooperative behavior that allow the procedure to be taken with local anesthetic.

Exclusion criteria

Exclusion criteria: The exclusion criteria are: allergies to local anesthetics or sulfites; history of significant medical conditions; taking any medications that might affect anesthetic assessment; and active state of pathosis in the area of injection.

Design outcomes

Primary

Measure	Time frame
The primary endpoint evaluated (1) will be pain measured by the reported pain of the transient and postoperative infantile patient after administration of analgesic prior to the primary molar extraction procedure;Primary endpoint (2) will be the anesthetic efficacy of articaine 4% with epinephrine 1: 100,000 compared to 2% lidocaine with epinephrine 1: 100,000 through vestibular infiltrative technique for primary molar extraction in patient comfort, verified by pain reported	—

Measure

Time frame

The primary endpoint evaluated (1) will be pain measured by the reported pain of the transient and postoperative infantile patient after administration of analgesic prior to the primary molar extraction procedure;Primary endpoint (2) will be the anesthetic efficacy of articaine 4% with epinephrine 1: 100,000 compared to 2% lidocaine with epinephrine 1: 100,000 through vestibular infiltrative technique for primary molar extraction in patient comfort, verified by pain reported

—

Secondary

Measure	Time frame
The secondary outcome will be children behavior during the procedure evaluated with Frankl and Venham's scale.;(b) children's anxiety before and after procedures (Facial Image Scale - FIS) and parents' anxiety before and after procedures (Dental Anxiety Scale - DAS);(c) Quality of life related to children's oral health;(d) Frequency of postoperative adverse events between local anesthetics performed with different anesthetic agents and between use of preoperative analgesic or placebo	—

Measure

Time frame

The secondary outcome will be children behavior during the procedure evaluated with Frankl and Venham's scale.;(b) children's anxiety before and after procedures (Facial Image Scale - FIS) and parents' anxiety before and after procedures (Dental Anxiety Scale - DAS);(c) Quality of life related to children's oral health;(d) Frequency of postoperative adverse events between local anesthetics performed with different anesthetic agents and between use of preoperative analgesic or placebo

—

Countries

Brazil

Contacts

Public ContactLuiz Toledo

Universidade Federal de Santa Catarina

cep.propesq@contato.ufsc.br(48)3721-6094

Outcome results

None listed

Source: REBEC (via WHO ICTRP)