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New treatment option for Anesthesia
Official title Intravenous Dexmedetomidine as an Adjuvant to Locoregional Anesthesia in Pediatric Surgery
ClinicalTrials.gov ID: NCT06736483
What this study is testing
What is Dexmedetomidine?
Dexmedetomidine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for anesthesia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The main objective of this study is to study the impact of intravenous dexmedetomidine combined with locoregional anesthesia on postoperative pain in children undergoing surgery. Secondary objectives was to compare beetwen groups : Post-operative pain; opioid consumption; incidence of emergence delirium, post-operative behavioral disorders, length of stay in the PACU, adverse events , parental satisfaction and quality of life.The goal of this clinical trial is to assess intravenous dexmedetomidine to prevent post-operative pain in children undergoing surgery.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 7
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
- Local-regional anesthesia via Transversus Abdominis Plane (TAP) block and/or pudendal block
- National health insurance coverage
- Have obtained signed informed consent from holders of parental authority
You likely can't join if
- Patient under 1 or over 8 years old
- Patients with allergies to local anesthetics
- Patient 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...
- 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
- Local-regional anesthesia via Transversus Abdominis Plane (TAP) block and/or pudendal block
- National health insurance coverage
- Have obtained signed informed consent from holders of parental authority
- American Society of Anesthesiology (ASA) score : 1-2
- French read, written and spoken by legal representatives
- Patient under 1 or over 8 years old
- Patients with allergies to local anesthetics
- Patient 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.
Where it's taking place
- Montpellier, France, France
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, 1 year to 7 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montpellier, France, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.