Postoperative Complication After G.A

Complication of Anesthesia Clinical Trial

Official title:

Postoperative Complications in Children Following Dental General Anesthesia and it's Correlation With The Type of Dental Treatment Done.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05758974
• Other study ID #: complication of G.A
• Status: Not yet recruiting
• Start date: September 20, 2023
• Est. completion date: November 12, 2024

Study information

• Verified date: February 2023
• Source: Cairo University
• Contact: sawsan Ah Ebrahim, master
• Phone: 00201019792988
• Email: sawsan.ebrahim[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: November 12, 2024
• Est. primary completion date: September 20, 2024
• Gender: All
• Age group: 3 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Complication of Anesthesia
• Postoperative Complications

Intervention

Procedure:
• dental treatment
Extraction, pulp therapy or both

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (1)

Deng XY, Zhang YH, Zou J, Zhang Q. [Investigation of postoperative complications in children after dental therapy under general anesthesia]. Hua Xi Kou Qiang Yi Xue Za Zhi. 2020 Jun 1;38(3):284-289. doi: 10.7518/hxkq.2020.03.010. Chinese. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain	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."	Baseline
Secondary	Fever	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.	Baseline
Secondary	Weariness and drowsiness	That would be assessed through questionnaire.by asking the patient binary yes or no questions.	Baseline