2024-514550-73-00招募中2 期
Intravenous dexmedetomidine as an adjuvant to locoregional anesthesia in pediatric surgery: a prospective, randomized, double-blind, placebo-controlled study. DEXPED
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Number of patients using a rescue analgesic (Nalbuphine, Nubain®) in the PACU between the two arms
研究概览
简要总结
To study the impact of intravenous (IV) dexmedetomidine combined with locoregional anesthesia (LRA) on postoperative pain in children undergoing surgery
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •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
结局指标
主要结局
Number of patients using a rescue analgesic (Nalbuphine, Nubain®) in the PACU between the two arms
Number of patients using a rescue analgesic (Nalbuphine, Nubain®) in the PACU between the two arms
次要结局
- 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
- Intraoperative morphine consumption: Sufentanil, number of re-injections (0.1 µg/kg) required
- Dose in milligrams of emergency analgesics in the PACU
- Incidence of opioid-related side effects (respiratory complications, postoperative nausea and vomiting)
- Length of stay (from PACU entry to discharge based on Aldrete score > 9)
- Incidence of emergence delirium in the PACU according to the Pediatric Anesthesia Emergence Delirium (PAED) scale
- Post-Hospitalization Behavior Questionnaire at 7 days, 3, and 6 months
- Postoperative Pain Measure For Parents at 7 days, 3, and 6 months
- Post-operative quality of life questionnaire pedsQL at 7 days, 3 and 6 months
研究者
ISSA Amelle
Scientific
Centre Hospitalier Universitaire De Montpellier
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Scalp Block Versus Scalp Infiltration With Dexmedetomidine and Local Anesthetic for Post Craniotomy PainHeadacheNCT02866409NAVNEH SAMAGH150
招募中
2 期
Intravenous Dexmedetomidine as an Adjuvant to Locoregional Anesthesia in Pediatric SurgeryAnesthesiaPediatric SurgeryNCT06736483University Hospital, Montpellier200
招募中
4 期
DEXMEDETOMIDINE in NORMAL VAGINAL DELIVERYPainless Vainal LabourNCT05840328Menoufia University60
招募中
不适用
Th Effects of a Drug Dexmedotemidine in Regional Anesthesia in Participants Undergoing Upper Limb SurgeriesSupraclavicular Brachial Plexus BlockNCT04981951Zaher Nazzal70
已完成
3 期
Ultrasound-guided Regional Anesthesia vs Local Infiltration Anesthesia With Dexmedetomidine and RopivacainePain, PostoperativeAnesthesia, LocalGonarthrosisNCT04697537Medical University of Graz50