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

Post-operative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03739567
• Other study ID #: CEBD-CU-2018-11-08
• Status: Not yet recruiting
• Start date: March 1, 2019
• Est. completion date: June 1, 2019

Study information

• Verified date: November 2018
• Source: Cairo University
• Contact: marwa mostafa ahmed, B.D.S.
• Phone: 01003572429
• Email: marwa.mostafa[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Observational

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

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?

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: June 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Post-operative Pain

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dental Discomfort Questionnaire	Numerical Rating Pain Scale (Outcome measuring device)	3 monthes