Intravenous Dexamethasone for PENG Block Analgesia in Children Undergoing Hip Surgery
NCT07924670, Phase 4, Not yet recruiting, Poznan University of Medical Sciences
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Intravenous Dexamethasone for PENG Block Analgesia in Children Undergoing Hip Surgery | ClinicalTrials.gov |
| NCT number | NCT07924670 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 4 | ClinicalTrials.gov |
| Enrollment | 90 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Poznan University of Medical Sciences | ClinicalTrials.gov |
| Conditions | Hip Surgeries, DDH | ClinicalTrials.gov |
| Interventions | Dexamethasone (0.1 mg/kg), Dexamethasone (0.2 mg/kg), 0.9 % Normal Saline | ClinicalTrials.gov |
| First posted | 2026-11-09 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Cumulative Intravenous Nalbuphine Consumption | 48 hours after surgery | Total cumulative dose of intravenous nalbuphine administered as rescue analgesia during the first 48 hours after surgery. Nalbuphine consumption will be normalized to body weight and expressed as mg/kg. A value of 0 mg/kg will be recorded for participants who do not require rescue nalbuphine during the 48-hour observation period. | ClinicalTrials.gov |
| Secondary | Time to First Rescue Nalbuphine Administration | 48 hours after surgery | Time in hours from the end of surgery to the first administration of intravenous nalbuphine for postoperative rescue analgesia. Participants who do not require nalbuphine during the 48-hour observation period will be censored at 48 hours. | ClinicalTrials.gov |
| Secondary | Postoperative Pain Intensity | 12 hours after surgery | Postoperative pain intensity will be assessed using the Numeric Rating Scale (NRS) in participants able to provide reliable self-report. The NRS ranges from 0 (no pain; minimum score) to 10 (worst imaginable pain; maximum score). In participants unable to provide reliable self-report, the Face, Legs, Activity, Cry, Consolability (FLACC) scale will be used. Its five domains are each scored from 0 to 2 and summed, giving a total score from 0 (minimum) to 10 (maximum). For both scales, higher scores indicate greater pain intensity and a worse outcome. | ClinicalTrials.gov |
| Secondary | Postoperative Pain Intensity | 24 hours after surgery | Postoperative pain intensity will be assessed using the Numeric Rating Scale (NRS) in participants able to provide reliable self-report. The NRS ranges from 0 (no pain; minimum score) to 10 (worst imaginable pain; maximum score). In participants unable to provide reliable self-report, the Face, Legs, Activity, Cry, Consolability (FLACC) scale will be used. Its five domains are each scored from 0 to 2 and summed, giving a total score from 0 (minimum) to 10 (maximum). For both scales, higher scores indicate greater pain intensity and a worse outcome. | ClinicalTrials.gov |
| Secondary | Postoperative Pain Intensity | 6 hours after surgery | Postoperative pain intensity will be assessed using the Numeric Rating Scale (NRS) in participants able to provide reliable self-report. The NRS ranges from 0 (no pain; minimum score) to 10 (worst imaginable pain; maximum score). In participants unable to provide reliable self-report, the Face, Legs, Activity, Cry, Consolability (FLACC) scale will be used. Its five domains are each scored from 0 to 2 and summed, giving a total score from 0 (minimum) to 10 (maximum). For both scales, higher scores indicate greater pain intensity and a worse outcome. | ClinicalTrials.gov |
| Secondary | Postoperative Pain Intensity | 48 hours after surgery | Postoperative pain intensity will be assessed using the Numeric Rating Scale (NRS) in participants able to provide reliable self-report. The NRS ranges from 0 (no pain; minimum score) to 10 (worst imaginable pain; maximum score). In participants unable to provide reliable self-report, the Face, Legs, Activity, Cry, Consolability (FLACC) scale will be used. Its five domains are each scored from 0 to 2 and summed, giving a total score from 0 (minimum) to 10 (maximum). For both scales, higher scores indicate greater pain intensity and a worse outcome. | ClinicalTrials.gov |
| Secondary | Proportion of Participants Requiring Rescue Nalbuphine | 48 hours after surgery | Proportion of participants who receive at least one dose of intravenous nalbuphine for rescue analgesia during the first 48 hours after surgery. | ClinicalTrials.gov |
| Secondary | Incidence of Postoperative Nausea and Vomiting | 48 hours after surgery | Occurrence of postoperative nausea and/or vomiting during the first 48 hours after surgery. The need for rescue antiemetic medication will also be recorded. | ClinicalTrials.gov |
| Secondary | Incidence of Adverse Events | From administration of the study intervention to 30 days after surgery | Occurrence of adverse events potentially related to intravenous dexamethasone or the PENG block, including clinically significant hyperglycemia, infection, neurological complications, local anesthetic systemic toxicity, or other unexpected adverse events. | ClinicalTrials.gov |
| Secondary | Blood Glucose Concentration | 6 hours after surgery | Blood glucose concentration will be measured to assess dexamethasone-associated perioperative hyperglycemia. Glucose values will be recorded in mg/dL before surgery and at predefined postoperative time points. | ClinicalTrials.gov |
| Secondary | Blood Glucose Concentration | 12 hours after surgery | Blood glucose concentration will be measured to assess dexamethasone-associated perioperative hyperglycemia. Glucose values will be recorded in mg/dL before surgery and at predefined postoperative time points. | ClinicalTrials.gov |
| Secondary | Blood Glucose Concentration | 24 hours after surgery | Blood glucose concentration will be measured to assess dexamethasone-associated perioperative hyperglycemia. Glucose values will be recorded in mg/dL before surgery and at predefined postoperative time points. | ClinicalTrials.gov |
| Secondary | Blood Glucose Concentration | 48 hours after surgery | Blood glucose concentration will be measured to assess dexamethasone-associated perioperative hyperglycemia. Glucose values will be recorded in mg/dL before surgery and at predefined postoperative time points. | 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)