Postoperative Complication After G.A

Not yet recruiting

• Conditions: Complication of Anesthesia

• Registration Number: NCT05758974
• Lead Sponsor: Cairo University

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?

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 Timeline

• Study First Submitted: 2023-01-20
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-24
• Last Update Submitted: 2023-02-24
• Study First Posted: 2023-03-08
• Last Update Posted: 2023-03-08
• Study Start: 2023-09-20
• Primary Completion: 2024-09-20
• Study Completion: 2024-11-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
Weariness and drowsiness	Baseline	That would be assessed through questionnaire.by asking the patient binary yes or no questions.