A Phase 4 interventional study of Dexamethasone (0.1 mg/kg) and Dexamethasone (0.2 mg/kg) in Hip Surgeries and DDH, sponsored by Poznan University of Medical Sciences. Not yet recruiting at 1 site in Poland. Open to participants aged 4 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Poznan University of Medical Sciences · Phase 4, Interventional, and Treatment
This randomized, double-blind, placebo-controlled study will evaluate the effect of intravenous dexamethasone on postoperative analgesia in children undergoing hip surgery with a pericapsular nerve group (PENG) block.
A total of 90 participants will be randomly assigned in a 1:1:1 ratio to receive intravenous placebo, dexamethasone 0.1 mg/kg, or dexamethasone 0.2 mg/kg. All participants will receive a PENG block as part of standardized multimodal postoperative analgesia.
The primary outcome will be cumulative intravenous nalbuphine consumption, expressed as mg/kg, during the first 48 hours after surgery. Secondary outcomes will include time to first rescue nalbuphine administration, postoperative pain intensity, the proportion of participants requiring rescue opioid analgesia, postoperative nausea and vomiting, blood glucose levels, and adverse events.
The study aims to determine whether intravenous dexamethasone reduces postoperative opioid requirements after PENG block and whether the analgesic effect differs between the two studied dexamethasone doses.
This prospective, randomized, double-blind, placebo-controlled, parallel-group study will investigate the effect of two doses of intravenous dexamethasone on postoperative analgesia in children undergoing elective hip surgery with a pericapsular nerve group (PENG) block.
A total of 90 participants will be enrolled and randomly assigned in a 1:1:1 ratio to one of three study groups: intravenous placebo, intravenous dexamethasone 0.1 mg/kg, or intravenous dexamethasone 0.2 mg/kg. Study medication will be administered intravenously as part of the perioperative anesthetic management. Participants, their parents or legal guardians, clinicians involved in postoperative care and outcome assessment, and investigators analyzing the study outcomes will remain blinded to treatment allocation.
All participants will undergo general anesthesia and ultrasound-guided PENG block according to a standardized institutional protocol. Postoperative analgesia and criteria for administration of rescue analgesia will be standardized across all study groups.
The primary outcome will be cumulative intravenous nalbuphine consumption during the first 48 hours after surgery, normalized to body weight and expressed as mg/kg.
Secondary outcomes will include time from the end of surgery to the first administration of rescue nalbuphine, postoperative pain intensity at predefined time points, the proportion of participants requiring rescue opioid analgesia, and postoperative nausea and vomiting. Blood glucose concentrations and adverse events will also be assessed to evaluate the safety of the studied dexamethasone doses.
The study is designed to evaluate whether intravenous dexamethasone reduces postoperative opioid requirements following PENG block compared with placebo and to explore whether the analgesic effect differs between dexamethasone doses of 0.1 mg/kg and 0.2 mg/kg.
Poznan University of Medical Sciences is the lead sponsor of 151 studies on the registry; 41 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive intravenous placebo (0.9% sodium chloride) in addition to standardized spinal anesthesia and an ultrasound-guided PENG block.
Drug: 0.9 % Normal Saline
Participants will receive intravenous dexamethasone 0.1 mg/kg in addition to standardized spinal anesthesia and an ultrasound-guided PENG block.
Drug: Dexamethasone (0.1 mg/kg)
Participants will receive intravenous dexamethasone 0.2 mg/kg in addition to standardized spinal anesthesia and an ultrasound-guided PENG block.
Drug: Dexamethasone (0.2 mg/kg)
Drug page: Dexamethasone
Dexamethasone will be administered intravenously as a single perioperative dose of 0.1 mg/kg according to randomized treatment allocation.
Drug page: Dexamethasone
Dexamethasone will be administered intravenously as a single perioperative dose of 0.2 mg/kg according to randomized treatment allocation
Participants will receive intravenous placebo (0.9% sodium chloride) in addition to standardized spinal anesthesia and an ultrasound-guided PENG block.
Cumulative Intravenous Nalbuphine Consumption
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.
Time frame: 48 hours after surgery
Time to First Rescue Nalbuphine Administration
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.
Time frame: 48 hours after surgery
Postoperative Pain Intensity
Postoperative pain intensity will be assessed using the Numeric Rating Scale (NRS; 0-10) in participants able to provide reliable self-report, or the Face, Legs, Activity, Cry, Consolability (FLACC) scale (0-10) in participants unable to provide reliable self-report. Higher scores indicate greater pain intensity.
Time frame: 12 hours after surgery
Postoperative Pain Intensity
Postoperative pain intensity will be assessed using the Numeric Rating Scale (NRS; 0-10) in participants able to provide reliable self-report, or the Face, Legs, Activity, Cry, Consolability (FLACC) scale (0-10) in participants unable to provide reliable self-report. Higher scores indicate greater pain intensity.
Time frame: 24 hours after surgery
Postoperative Pain Intensity
Postoperative pain intensity will be assessed using the Numeric Rating Scale (NRS; 0-10) in participants able to provide reliable self-report, or the Face, Legs, Activity, Cry, Consolability (FLACC) scale (0-10) in participants unable to provide reliable self-report. Higher scores indicate greater pain intensity.
Time frame: 6 hours after surgery
Postoperative Pain Intensity
Postoperative pain intensity will be assessed using the Numeric Rating Scale (NRS; 0-10) in participants able to provide reliable self-report, or the Face, Legs, Activity, Cry, Consolability (FLACC) scale (0-10) in participants unable to provide reliable self-report. Higher scores indicate greater pain intensity.
Time frame: 48 hours after surgery
Proportion of Participants Requiring Rescue Nalbuphine
Proportion of participants who receive at least one dose of intravenous nalbuphine for rescue analgesia during the first 48 hours after surgery.
Time frame: 48 hours after surgery
Incidence of Postoperative Nausea and Vomiting
Occurrence of postoperative nausea and/or vomiting during the first 48 hours after surgery. The need for rescue antiemetic medication will also be recorded.
Time frame: 48 hours after surgery
Incidence of Adverse Events
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.
Time frame: From administration of the study intervention to 30 days after surgery
Blood Glucose Concentration
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.
Time frame: 6 hours after surgery
Blood Glucose Concentration
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.
Time frame: 12 hours after surgery
Blood Glucose Concentration
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.
Time frame: 24 hours after surgery
Blood Glucose Concentration
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.
Time frame: 48 hours after surgery
Plan to share: Yes — Individual participant data (IPD) will not be made publicly available. This study involves a pediatric population, and individual-level data will be maintained in accordance with applicable ethical, institutional, and data protection requirements.
Supporting information: Clinical study report, Analytic code
Time frame: Beginning immediately after publication of the main study results and continuing for 5 years after publication.
Access criteria: available upon reasonable request from the corresponding author
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexamethasone
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