Postoperative Pain in Children Aged From 3 to 5 Years Following Full Mouth

Status Not yet recruiting

Clinical Trial Summary

the purpose of this study is monitoring Postoperative pain in Children Aged from 3 to 5 years following Full mouth Dental Rehabilitation under General Anesthesia

Clinical Trial Description

The study's investigators will record all data related to the immediate postoperative period during the child's stay in the post anesthetic recovery room (PAR).

Just prior to discharge home, the child's discomfort will be measured using Face, Legs, Activity, Cry, and Consolability Pain Assessment Tool (FLACC).

Postoperative data is collected by the same investigator who contacted caregivers by phone at 4 postoperative times: 1, 3, 7, and 30 days after the DRGA using The Dental Questionnaire.

When a participant cannot be reached on the scheduled day, the information is collected on the nearest subsequent day.

The postoperative assessment included: the questioner and an inquiry about the use of medications; the child's ability to eat a regular diet; and "mouth-related" complaints other than dental discomfort.

Dental discomfort is assessed in this study by 2 scales:

the FLACC (Table 1) and The Dental Questioner (Table 2).

FLACC pain assessment tool. The FLACC scale was originally developed to quantify postoperative pain in infants from 2 months old to children up to 7-years-old.(7) This scale assesses 5 aspects of behavior: (F) facial expression; (L) leg movement; (A) activity; (C) cry; and (C) consolability. The range for the total score is from 0 (no pain) to 10 (intense pain). The examiner is standardized to use of the FLACC by a PAR nurse who was experienced in scoring pain with this scale.

The Dental Questioner. The questionnaire covered the following items: did the Child have pain, bleeding from dental origin, sore throat, fever, vomiting, inability to eat, sleepiness, drowsiness, cough, nausea or psychological changes? ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03739567
Study type	Observational
Source	Cairo University
Contact	marwa mostafa ahmed, B.D.S.
Phone	01003572429
Email	marwa.mostafa@dentistry.cu.edu.eg
Status	Not yet recruiting
Phase
Start date	March 1, 2019
Completion date	June 1, 2019

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Postoperative Pain in Children Aged From 3 to 5 Years Following Full Mouth Dental Rehabilitation Under General Anesthesia. A Cross-sectional Study. Rehabilitation Under General Anesthesia

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms