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

Postoperative Pain in Children Aged From 3 to 5 Years Following Full Mouth Dental Rehabilitation Under General Anesthesia

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

Study Overview

• Status: Unknown
• Conditions: Post-operative Pain

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?

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 5 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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 ).

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dental Discomfort Questionnaire	Numerical Rating Pain Scale (Outcome measuring device)	3 monthes

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Amr ezzat, professor, Cairo University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 1, 2019
• Primary Completion (ANTICIPATED): March 1, 2019
• Study Completion (ANTICIPATED): June 1, 2019

Study Registration Dates

• First Submitted: November 7, 2018
• First Submitted That Met QC Criteria: November 9, 2018
• First Posted (ACTUAL): November 14, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 5, 2019
• Last Update Submitted That Met QC Criteria: March 2, 2019
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: General anesthesia, clinical manifestations. .
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: CEBD-CU-2018-11-08

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No