Comparing two pain relief methods for boys undergoing circumcision
Comparison of Caudal Blockade and Dorsal Penile Nerve Block With and Without the Intravenous Administration of Dexamethasone for Analgesia After Paediatric Male Circumcision: a Single Centre Randomized-controlled Trial
PHASE4 · Algemeen Ziekenhuis Maria Middelares · NCT05598255
This study is testing which pain relief method works better for boys aged 1 to 7 after circumcision, and if adding a medication helps with pain.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 1 Year to 7 Years |
| Sex | Male |
| Sponsor | Algemeen Ziekenhuis Maria Middelares (other) |
| Locations | 1 site (Gent, Oost Vlaanderen) |
| Trial ID | NCT05598255 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of two locoregional anesthesia techniques, caudal blockade and dorsal penile nerve block, in providing postoperative pain relief for male infants undergoing circumcision. Participants aged 1 to 7 years will be randomly assigned to receive either technique, with some receiving intravenous dexamethasone as an adjuvant. Pain levels will be assessed at multiple time points after the procedure using the FLACC scale. The goal is to determine which method offers better analgesia and if dexamethasone enhances the effect.
Who should consider this trial
Good fit: Ideal candidates are male pediatric patients aged 1 to 7 years scheduled for circumcision.
Not a fit: Patients with allergies to the study medications or those with certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for infants undergoing circumcision.
How similar studies have performed: Previous studies have shown the effectiveness of local anesthetic techniques for postoperative pain relief, but this specific comparison with dexamethasone is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male paediatric patients, between ≥ 1 and \< 7 years of age * Patients scheduled for paediatric male circumcision (sleeve resection technique) * Signed written informed consent form Exclusion Criteria: * Patients known with allergy to study medication (in this case levobupivacaine, dexamethasone, tramadol, diclofenac, paracetamol, sufentanil) * ASA score 3 or higher (ASA physical satus classification system) * Delayed motor development/inability to stand up * Patients who receive medication that could possibly interact with levobupivacaine (mexiletine, ketoconazole, theophylline) * Patients who simultaneous participate in another interventional clinical trial * Inability of parents to understand Dutch in a sufficient way * Soft tissue infection in the area of the procedure * Coagulation disorder * Spina bifida * Autism spectrum disorder * Ulcus ventriculi and duodeni * Systemic fungal, bacterial and parasitic infections * Administration of live or live-attenuated vaccins during the use of dexamethasone
Where this trial is running
Gent, Oost Vlaanderen
- AZ Maria Middelares Gent — Gent, Oost Vlaanderen, Belgium (RECRUITING)
Study contacts
- Principal investigator: Joris Goossens, MD — Algemeen Ziekenhuis Maria Middelares
- Study coordinator: Joris Goossens, MD
- Email: joris.goossens@azmmsj.be
- Phone: +32 9 246 17 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Analgesic Effect, Locoregional technique, postoperative analgesic effects, caudal blockade, dorsal penile nerve block