Perfusion Index for Postoperative Pain Assessment in Pediatric Adenotonsillectomy
NCT07915804, Not applicable, Recruiting, Istanbul University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Perfusion Index for Postoperative Pain Assessment in Pediatric Adenotonsillectomy | ClinicalTrials.gov |
| NCT number | NCT07915804 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 50 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Istanbul University | ClinicalTrials.gov |
| Conditions | Postoperative Pain, Adenotonsillectomy, Pain, Pediatric | ClinicalTrials.gov |
| Interventions | Bilateral Intraoral Glossopharyngeal Nerve Block | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Correlation Between Perfusion Index and FLACC Pain Score | During the postoperative recovery period, up to 30 minutes after admission to the post-anesthesia care unit. | The correlation between postoperative perfusion index and the Face, Legs, Activity, Cry, Consolability (FLACC) Scale score will be evaluated in children aged 1-3 years. The FLACC Scale ranges from 0 to 10, with higher scores indicating greater pain intensity. Perfusion index will be calculated as the mean of three consecutive measurements obtained from the right index finger. The reported outcome will be the correlation coefficient between postoperative perfusion index and the FLACC Scale score. | ClinicalTrials.gov |
| Primary | Correlation Between Perfusion Index and Wong-Baker FACES Pain Score | During the postoperative recovery period, up to 30 minutes after admission to the post-anesthesia care unit. | The correlation between postoperative perfusion index and the Wong-Baker FACES Pain Rating Scale score will be evaluated in children older than 3 years. The Wong-Baker FACES Pain Rating Scale ranges from 0 to 10, with higher scores indicating greater pain intensity. Perfusion index will be calculated as the mean of three consecutive measurements obtained from the right index finger. The reported outcome will be the correlation coefficient between postoperative perfusion index and the Wong-Baker FACES Pain Rating Scale score. | ClinicalTrials.gov |
| Secondary | Change in Perfusion Index During the Perioperative Period | At preoperative baseline, 20 minutes after tracheal intubation, upon admission to the post-anesthesia care unit, and before discharge from the post-anesthesia care unit on the day of surgery. | Perfusion index values will be recorded at predefined perioperative time points, including the preoperative baseline, 20 minutes after tracheal intubation, upon admission to the PACU, and before discharge from the PACU. Three consecutive measurements will be obtained at each time point and the mean value will be used for analysis. Changes in PI over time and differences between the study groups will be evaluated. | ClinicalTrials.gov |
| Secondary | Postoperative Pain Score | Approximately 30 minutes after admission to the PACU | Postoperative pain severity will be assessed using age-appropriate validated pediatric pain scales. The FLACC scale will be used in children aged 1-3 years, and the Wong-Baker FACES Pain Rating Scale will be used in children older than 3 years. Both scales range from 0 to 10, with higher scores indicating greater pain intensity. | ClinicalTrials.gov |
| Secondary | Requirement for Rescue Analgesia | During the PACU stay on the day of surgery | The number and proportion of participants requiring rescue analgesia during postoperative recovery will be recorded. Intravenous ibuprofen 10 mg/kg will be administered according to the predefined postoperative pain criteria. | ClinicalTrials.gov |
| Secondary | Incidence of Postoperative Nausea and Vomiting | During the PACU stay on the day of surgery | The incidence of postoperative nausea and/or vomiting will be recorded during postoperative recovery. | ClinicalTrials.gov |
| Secondary | Perioperative Heart Rate | At preoperative baseline, 20 minutes after tracheal intubation, upon admission to the post-anesthesia care unit, and before discharge from the post-anesthesia care unit on the day of surgery. | Heart rate, measured in beats per minute, will be recorded at predefined perioperative time points, including the preoperative baseline, 20 minutes after tracheal intubation, before extubation, and during admission to and discharge from the PACU. | ClinicalTrials.gov |
| Secondary | Perioperative Systolic Blood Pressure | At preoperative baseline, 20 minutes after tracheal intubation, upon admission to the post-anesthesia care unit, and before discharge from the post-anesthesia care unit on the day of surgery. | Systolic blood pressure, measured in mmHg, will be recorded at predefined perioperative time points, including the preoperative baseline, 20 minutes after tracheal intubation, before extubation, and during admission to and discharge from the PACU. | ClinicalTrials.gov |
| Secondary | Perioperative Diastolic Blood Pressure | At preoperative baseline, 20 minutes after tracheal intubation, upon admission to the post-anesthesia care unit, and before discharge from the post-anesthesia care unit on the day of surgery. | Diastolic blood pressure , measured in mmHg, will be recorded at predefined perioperative time points, including the preoperative baseline, 20 minutes after tracheal intubation, before extubation, and during admission to and discharge from the PACU. | ClinicalTrials.gov |
| Secondary | Peripheral Oxygen Saturation | At preoperative baseline, 20 minutes after tracheal intubation, upon admission to the post-anesthesia care unit, and before discharge from the post-anesthesia care unit on the day of surgery. | Peripheral oxygen saturation, expressed as a percentage, will be recorded at predefined perioperative time points, including the preoperative baseline, 20 minutes after tracheal intubation, before extubation, and during admission to and discharge from the PACU. | 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 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
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)