Dexmedetomidine for Pediatric surgery | Postoperative pain

Inclusion criteria

• {"criterion_text":"- Age 1 to 7 years old male or female\n- To be hospitalized for scheduled urovisceral orchidopexy or peritoneovaginal canal surgery (inguinal hernia or hydrocele cure) on an outpatient basis or conventional hospitalization\n- Locoregional anesthesia via Transversus Abdominis Plane (TAP) block and/or pudendal block\n- National health insurance coverage\n- Signed informed consent from holders of parental authority\n- American Society of Anesthesiology (ASA) score: 1-2\n- French read, written and spoken by legal representatives"}

Exclusion criteria

• {"criterion_text":"- Patients under 1 or over 8 years old\n- Patients with allergies to local anesthetics\n- Patients with a contraindication to locoregional anesthesia: coagulation disorder or infection (fasciocutaneous) in the puncture zone\n- 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)\n- Patients with delayed psychological development, cognitive or behavioral disorders, or severe neurological pathology\n- Patients and/or parents who refused to participate in the study\n- Proven allergy or contraindication to dexmedetomidine or nalbuphine\n- Previous study participants"}

Primary endpoints

• {"endpoint_text":"- Number of patients using a rescue analgesic (Nalbuphine, Nubain®) in the PACU between the two arms","definition_or_measurement_approach":"Measured as number of patients using a rescue analgesic (Nalbuphine, Nubain®) in the Post-Anesthesia Care Unit (PACU) between the two arms."}

Secondary endpoints

• {"endpoint_text":"- Assessment of postoperative pain using the Face Legs Activity Cry Consolability (FLACC) scale: on admission and every 15 minutes until discharge from the PACU, then before returning home","definition_or_measurement_approach":"Postoperative pain measured by FLACC scale on PACU admission and every 15 minutes until PACU discharge, then before return home."}
• {"endpoint_text":"- Intraoperative morphine consumption: Sufentanil, number of re-injections (0.1 µg/kg) required","definition_or_measurement_approach":"Measured as number of sufentanil re-injections (0.1 µg/kg) required intraoperatively."}
• {"endpoint_text":"- Dose in milligrams of emergency analgesics in the PACU","definition_or_measurement_approach":"Measured as total dose (mg) of rescue/emergency analgesics administered in PACU."}
• {"endpoint_text":"- Incidence of opioid-related side effects (respiratory complications, postoperative nausea and vomiting)","definition_or_measurement_approach":"Measured as incidence of specified opioid-related adverse events (respiratory complications, postoperative nausea and vomiting)."}
• {"endpoint_text":"- Length of stay (from PACU entry to discharge based on Aldrete score > 9)","definition_or_measurement_approach":"Measured as time from PACU entry to PACU discharge defined by Aldrete score > 9."}
• {"endpoint_text":"- Incidence of emergence delirium in the PACU according to the Pediatric Anesthesia Emergence Delirium (PAED) scale","definition_or_measurement_approach":"Measured as incidence of emergence delirium in PACU using PAED scale."}
• {"endpoint_text":"- Post-Hospitalization Behavior Questionnaire at 7 days, 3, and 6 months","definition_or_measurement_approach":"Measured by responses to the Post-Hospitalization Behavior Questionnaire at post-op day 7, 3 months, and 6 months."}
• {"endpoint_text":"- Postoperative Pain Measure For Parents at 7 days, 3, and 6 months","definition_or_measurement_approach":"Measured by the Postoperative Pain Measure For Parents (PPMP) at day 7, 3 months, and 6 months."}
• {"endpoint_text":"- Post-operative quality of life questionnaire pedsQL at 7 days, 3 and 6 months","definition_or_measurement_approach":"Measured by the PedsQL quality of life questionnaire at day 7, 3 months, and 6 months postoperatively."}

France

Earliest CTIS Part Ii Submission Date

28-10-2024

Latest Decision Or Authorization Date

23-01-2026

Processing Time Days

452

Number Of Sites

2

Number Of Participants

200

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Montpellier

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France