Postoperative Complication After G.A

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05758974
Collaborator
(none)
110
13.8

Study Details

Study Description

Brief Summary

What are the possible postoperative complications that may occur for children following dental treatment under general anaesthesia and is there a correlation between those complications and type of dental treatment done?

Condition or Disease Intervention/Treatment Phase
  • Procedure: dental treatment

Detailed Description

Nowadays, early childhood caries (ECC) remains a significant challenge of public health in Egyptian children. In most cases, children with ECC could accept dental treatment under non-pharmacological behavior management or sedation. However, some very young children or those suffering severe anxiety, mental or physical disabilities, could only be treated under dental general anesthesia (DGA).

Dental general anesthesia (DGA) is a safe and high-quality restorative and preventive treatment option for children with severe early childhood caries (S-ECC), who require extensive dental treatment and exhibit anxiety and emotional or cognitive immaturity or are medically compromised. However, several postoperative complications have been reported in children under DGA in many studies.

For a day-stay, general anesthesia procedure to be an acceptable option, care during and after surgery must be of the highest quality, and postoperative complications must be minimized.

Study Design

Study Type:
Observational
Anticipated Enrollment :
110 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Postoperative Complications in Children Following Dental General Anesthesia and it's Correlation With The Type of Dental Treatment Done.
Anticipated Study Start Date :
Sep 20, 2023
Anticipated Primary Completion Date :
Sep 20, 2024
Anticipated Study Completion Date :
Nov 12, 2024

Outcome Measures

Primary Outcome Measures

  1. Postoperative pain [Baseline]

    pain would be assessed through the faces pain scale- revised this scale is self-report measure of pain intensity for children. These six faces expression show how much something can hurt, face 1 take score 0 no pain as minimum limit, face 2 take score 2, face 3 take score 4, face 4 take score 6, face 5 take score 8, face 6 take score 10 that the maximum limit "Very much pain."

Secondary Outcome Measures

  1. Fever [Baseline]

    postoperative fever would be assessed through thermometer, the range of normal body temperature from (36,5 _37,5) °C. from (37,5- 38) ° Cit considers low grade fever. Above 38° C it considers high grade fever. Fever may be accompanied by irritable or very uncomfortable. poor eye contact with the surrounding, vomits repeatedly, severe diarrhea, seizures, pain. , severe headache, muscle weakness, difficulty breathing.

  2. Weariness and drowsiness [Baseline]

    That would be assessed through questionnaire.by asking the patient binary yes or no questions.

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 6 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  1. Children with age range from 3 to 6 years old .

  2. Children affected by dental caries in more than 4 primary teeth.

  3. Uncooperative child indicated for treatment under G.A

  4. Classified by American Society of Anaesthesiologists Physical Status as Class 1

  5. Parents accepted to participate and willing to sign an informed consent.

Exclusion Criteria:
    1. The children whose guardians or caregivers have a problem in communicating with the medical staff

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Sawsan Ahmed Talaat, principal investigator in ministry of health,the health unit in Ibn betk fifth district in 6 October, Cairo University
ClinicalTrials.gov Identifier:
NCT05758974
Other Study ID Numbers:
  • complication of G.A
First Posted:
Mar 8, 2023
Last Update Posted:
Mar 8, 2023
Last Verified:
Feb 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 8, 2023