Complication of AnesthesiaNCT05758974
Postoperative Complication After G.A
An observational study of Complication of Anesthesia, run by Cairo University.
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? Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Complication of Anesthesia
- What is being tested?
- dental treatment
- Type of treatment
- Surgery or procedure
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2023to 12 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- Child
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.
Who may be able to join
- Children with age range from 3 to 6 years old .
- Children affected by dental caries in more than 4 primary teeth.
- Uncooperative child indicated for treatment under G.A
- Classified by American Society of Anaesthesiologists Physical Status as Class 1
- Parents accepted to participate and willing to sign an informed consent.
Who cannot join
- 1) The children whose guardians or caregivers have a problem in communicating with the medical staff
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Postoperative Complications in Children Following Dental General Anesthesia and it's Correlation With The Type of Dental Treatment Done.
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.
- Conditions
- Complication of Anesthesia
- Being tested
- dental treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental treatmentProcedure or surgery
Extraction, pulp therapy or both
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: Baseline
Secondary outcomes (2)
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.
Measured: Baseline
Weariness and drowsiness
That would be assessed through questionnaire.by asking the patient binary yes or no questions.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start20 Sep 2023 (estimated)
- Primary completion20 Sep 2024 (estimated)
- Study completion12 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complication of AnesthesiaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sawsan Ahmed Talaat, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05758974
- Sponsor's protocol ID
- complication of G.A
- Status last verified
- Feb 2023
- First submitted
- 20 Jan 2023
- Last updated
- 8 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Complications in Children Following Dental General Anesthesia and it's Correlation With The Type of Dental Treatment Done.
- ClinicalTrials.gov ID
- NCT05758974
- Acronym / sponsor ID
- complication of G.A
- Conditions
- Complication of Anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Sep 2023 (estimated)
- Primary completion
- 20 Sep 2024 (estimated)
- Study completion
- 12 Nov 2024 (estimated)
- First posted
- 8 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Age groups
- Child
- 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.
Key inclusion criteria (5 listed)
- Children with age range from 3 to 6 years old .
- Children affected by dental caries in more than 4 primary teeth.
- Uncooperative child indicated for treatment under G.A
- Classified by American Society of Anaesthesiologists Physical Status as Class 1
- Parents accepted to participate and willing to sign an informed consent.
Key exclusion criteria (1 listed)
- 1) The children whose guardians or caregivers have a problem in communicating with the medical staff
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dental treatmentExtraction, pulp therapy or both | Procedure or surgery | – |
Primary outcome
Postoperative pain
Time frame: 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."
2 secondary outcomes
Fever
Time frame: Baseline
Weariness and drowsiness
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Background: PubMed 32573136Deng 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Complication of Anesthesia, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact sawsan Ah Ebrahim, master (00201019792988, sawsan.ebrahim@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05758974, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2023; AzTrials last refreshed its copy on 30 Oct 2026.