CClinicalTrials.gg
Status unknownNCT05758974Updated Mar 8, 2023

Postoperative Complication After G.A

An observational study in Complication of Anesthesia, sponsored by Cairo University. Status unknown. Open to participants aged 3 Years to 6 Years. Per ClinicalTrials.gov, last updated 2023-03-08.

Sponsored by Cairo University · Observational

The sponsor has not verified this record recently (last verified Feb 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
110
Ages
3 Years to 6 Years
Sex
All
01

Study 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?

Read the 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.

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Conditions studied

  • Complication of Anesthesia
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In context

Postoperative Complications

1,233 studies on the registry are indexed under Postoperative Complications; 292 are open to participants now.

This study's planned enrollment of 110 is below the median of 254 across 519 observational studies indexed under Postoperative Complications.

Browse Postoperative Complications 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 6 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Children will be selected from general anaesthesia unit of Pediatric Dentistry Department, Faculty of Dentistry, Cairo University aged from 3-6 years according to the eligibility criteria.

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

Exclusion Criteria:

    1. The children whose guardians or caregivers have a problem in communicating with the medical staff
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
110 participants (estimated)
Patient registry
No

Interventions

  • Proceduredental treatment

    Extraction, pulp therapy or both

06

What researchers measure

Primary outcomes

  1. 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."

    Time frame: Baseline

Secondary outcomes

  1. 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.

    Time frame: Baseline

  2. Weariness and drowsiness

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

    Time frame: Baseline

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 32573136 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05758974
Lead sponsor
Cairo University
Responsible party
Sawsan Ahmed Talaat (principal investigator in ministry of health,the health unit in Ibn betk fifth district in 6 October, Cairo University) — Principal investigator
First posted
Mar 8, 2023
Start date
Sep 20, 2023 (estimated)
Primary completion
Sep 20, 2024 (estimated)
Completion
Nov 12, 2024 (estimated)
Last update
Mar 8, 2023

Study contacts

sawsan Ah Ebrahim, master
Contact
sawsan.ebrahim@dentistry.cu.edu.eg
00201019792988
ola mo omar, professor doctor
Contact
vice_postgrad@dentistry.cu.edu.eg
00201006030036

Oversight

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 Feb 2023. You cannot join it, but the record below documents what was studied.

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