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Intravenous Dexmedetomidine as an Adjuvant to Locoregional Anesthesia in Pediatric Surgery: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study. DEXPED
EU CTIS ID: 2024-514550-73-00
What this study is testing
To study the impact of intravenous (IV) dexmedetomidine combined with locoregional anesthesia (LRA) on postoperative pain in children undergoing surgery
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age 1 to 7 years old male or female
- To be hospitalized for scheduled urovisceral orchidopexy or peritoneovaginal canal surgery (inguinal hernia or hydrocele cure) on an outpatient basis or conventional hospitalization
- Locoregional anesthesia via Transversus Abdominis Plane (TAP) block and/or pudendal block
- National health insurance coverage
- Signed informed consent from holders of parental authority
- American Society of Anesthesiology (ASA) score: 1-2
You likely can't join if
- Patients under 1 or over 8 years old
- Patients with allergies to local anesthetics
- Patients with a contraindication to locoregional anesthesia: coagulation disorder or infection (fasciocutaneous) in the puncture zone
- Patients with a contraindication to dexmedetomidine (hypersensitivity to the active ingredient or one of the excipients, advanced heart block (level 2 or 3), uncontrolled hypotension, acute cerebrovascular pathologies)
- Patients with delayed psychological development, cognitive or behavioral disorders, or severe neurological pathology
- Patients and/or parents who refused to participate in the study
See the full eligibility criteria
- Age 1 to 7 years old male or female
- To be hospitalized for scheduled urovisceral orchidopexy or peritoneovaginal canal surgery (inguinal hernia or hydrocele cure) on an outpatient basis or conventional hospitalization
- Locoregional anesthesia via Transversus Abdominis Plane (TAP) block and/or pudendal block
- National health insurance coverage
- Signed informed consent from holders of parental authority
- American Society of Anesthesiology (ASA) score: 1-2
- French read, written and spoken by legal representatives
- Patients under 1 or over 8 years old
- Patients with allergies to local anesthetics
- Patients with a contraindication to locoregional anesthesia: coagulation disorder or infection (fasciocutaneous) in the puncture zone
- Patients with a contraindication to dexmedetomidine (hypersensitivity to the active ingredient or one of the excipients, advanced heart block (level 2 or 3), uncontrolled hypotension, acute cerebrovascular pathologies)
- Patients with delayed psychological development, cognitive or behavioral disorders, or severe neurological pathology
- Patients and/or parents who refused to participate in the study
- Proven allergy or contraindication to dexmedetomidine or nalbuphine
- Previous study participants
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.