Clinical trial NCT03739567: 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
Official title: Postoperative Pain in Children Aged From 3 to 5 Years Following Full Mouth Dental Rehabilitation Under General Anesthesia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Post-operative Pain
Keywords: General anesthesia, clinical manifestations. .
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-11-14
Enrollment: 200
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All children attending the outpatients' clinic of pediatric Dentistry and Public Health Faculty of Dentistry Cairo University-Egypt in the period of three months. (With average 30 patients in week ).

Brief 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

Detailed 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?

Eligibility criteria: Inclusion Criteria:

* Egyptian dental children undergoing full mouth dental rehabilitation under general anesthesia (3-5 years old )
* Children selected from pediatric dentistry and dental public health department Faculty of dentistry Cairo University
* Children with no developmental delay.
* Children with normal physical status.
* Parents who can be communicated well

Exclusion Criteria:

* Parents refusing participation in the study.
* Parents who cannot be communicated well
* Children with developmental abnormalities

Primary outcomes:
measure: Dental Discomfort Questionnaire
timeFrame: 3 monthes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Amr ezzat, professor
role: STUDY_DIRECTOR
References: