CClinicalTrials.gg
Status unknownNCT03739567Updated Mar 5, 2019

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

An observational study in Post-operative Pain, sponsored by Cairo University. Status unknown. Open to participants aged 3 Years to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-05.

Sponsored by Cairo University · Observational

The sponsor has not verified this record recently (last verified Nov 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
200
Ages
3 Years to 5 Years
Sex
All
01

Study 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

Read the 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?

02

Conditions studied

  • Post-operative Pain

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Keywords

  • General anesthesia, clinical manifestations. .
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's planned enrollment of 200 is above the median of 102 across 608 observational studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 5 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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 ).

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

Exclusion Criteria:

  • Parents refusing participation in the study.
  • Parents who cannot be communicated well
  • Children with developmental abnormalities
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
200 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Dental Discomfort Questionnaire

    Numerical Rating Pain Scale (Outcome measuring device)

    Time frame: 3 monthes

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03739567
Lead sponsor
Cairo University
Responsible party
Marwa Mostafa Ahmed (Master student in Cairo university, Cairo University) — Principal investigator
First posted
Nov 14, 2018
Start date
Mar 1, 2019 (estimated)
Primary completion
Mar 1, 2019 (estimated)
Completion
Jun 1, 2019 (estimated)
Last update
Mar 5, 2019

Study contacts

marwa mostafa ahmed, B.D.S.
Contact
marwa.mostafa@dentistry.cu.edu.eg
01003572429
Amr ezzat, professor
study director · Cairo University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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