Safety of Intraosseous Anaesthesia in Children With Haemophilia
NCT07916467, Not applicable, Not yet recruiting, Ankara Yildirim Beyazıt University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Safety of Intraosseous Anaesthesia in Children With Haemophilia | ClinicalTrials.gov |
| NCT number | NCT07916467 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 20 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Ankara Yildirim Beyazıt University | ClinicalTrials.gov |
| Conditions | Haemophilia A, Haemophilia B, Dental Caries | ClinicalTrials.gov |
| Interventions | Intraosseous Anaesthesia | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Injection-Site Bleeding Following Intraosseous Anaesthesia | 1, 2, 4, and 10 minutes after administration of intraosseous anaesthesia. | The presence or absence of bleeding at the injection site will be assessed at 1, 2, 4, and 10 minutes after intraosseous anaesthesia. The number and percentage of participants with injection-site bleeding at each time point will be recorded. Any requirement for additional local haemostatic measures will also be documented. | ClinicalTrials.gov |
| Primary | Injection-Site Haematoma Occurrence Following Intraosseous Anaesthesia | 1, 2, 4, and 10 minutes after administration of intraosseous anaesthesia. | The presence or absence of haematoma at the injection site will be assessed at 1, 2, 4, and 10 minutes after intraosseous anaesthesia. The number and percentage of participants with injection-site haematoma at each time point will be recorded. | ClinicalTrials.gov |
| Primary | Maximum Diameter of Injection-Site Haematoma Following Intraosseous Anaesthesia | 1, 2, 4, and 10 minutes after administration of intraosseous anaesthesia. | In participants who develop an injection-site haematoma, the maximum diameter of the haematoma will be measured in millimetres (mm) using a calliper at 1, 2, 4, and 10 minutes after intraosseous anaesthesia. Measurements will be recorded at each time point when a haematoma is present. | ClinicalTrials.gov |
| Primary | Participants With Postoperative Adverse Events Within 24 Hours After Intraosseous Anaesthesia | Within 24 hours after the procedure, assessed by telephone follow-up at 24 hours. | Postoperative adverse events will be assessed through a telephone interview with parents or legal guardians 24 hours after the procedure. Injection-site bleeding, haematoma, jaw stiffness, and other unexpected events will be recorded. Any contact with or presentation to the treatment centre and any requirement for factor replacement therapy or antifibrinolytic treatment (systemic or topical) due to bleeding or haematoma will also be documented. The number and percentage of participants experiencing at least one postoperative adverse event will be reported. | ClinicalTrials.gov |
| Secondary | Anaesthetic Success During Restorative Treatment | During restorative treatment, assessed immediately after completion of the procedure. | Anaesthetic success will be defined as completion of the planned restorative treatment without the need for supplementary local anaesthesia due to pain. Cases requiring supplementary local anaesthesia because of pain will be classified as anaesthetic failures. The number and percentage of participants with successful anaesthesia will be reported. The supplementary anaesthetic technique used, if any, will also be recorded. | ClinicalTrials.gov |
| Secondary | Wong-Baker FACES Pain Scores During Intraosseous Anaesthesia and Restorative Treatment | Immediately after intraosseous anaesthesia and immediately after completion of restorative treatment, during the same treatment visit. | Pain will be assessed using the Wong-Baker FACES Pain Rating Scale at two stages: immediately after intraosseous anaesthesia to evaluate pain experienced during injection, and immediately after restorative treatment to evaluate pain experienced during the restorative procedure. The scale consists of six faces corresponding to scores of 0, 2, 4, 6, 8, and 10, with higher scores indicating greater pain. Both pain scores will be recorded for each participant and compared. | ClinicalTrials.gov |
| Secondary | Pulse Rate During Intraosseous Anaesthesia and Restorative Treatment | Before intraosseous anaesthesia (baseline), during intraosseous anaesthesia, during cavity preparation, during matrix placement, during restorative material placement, and during finishing and polishing. | Pulse rate will be measured using a pulse oximeter and recorded in beats per minute (bpm) at six predefined stages: baseline (before anaesthesia), during intraosseous anaesthesia, during cavity preparation, during matrix placement, during restorative material placement, and during finishing and polishing. Changes in pulse rate across these stages will be evaluated. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 3
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)