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临床试验/NCT05530811
NCT05530811尚未招募不适用

Comparative Study Between Dexamethasone Plus Bupivacaine Versus Bupivacaine in Management of Suprazygomatic Maxillary Nerve Block in Cleft Palate Patients.

Assiut University0 个研究点目标入组 34 人开始时间: 2023年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
入组人数
34
主要终点
Postoperative pain score

研究概览

简要总结

Postoperative pain score, Faces, Legs, Activity, Cry, Consolability (FLACC) is the primary outcome. The secondary outcomes are the first-time requested analgesia, the number of children required analgesia, the total amount of analgesic requirements during first the 24 hours.

详细描述

Congenital cleft palate (CP) occurs in children at a rate of about 1.5 per 10 000 births , requiring early surgery, during the first months of life. The surgical procedure can be complicated by airway obstruction and respiratory complications. CP is painful in the first 24-48 hours following surgery.

Different treatment modalities have been used for reducing or ameliorating the pain following cleft palate repair. These include opioids, paracetamol, non steroidal anti-inflammatory drugs (NSAIDs). However, the analgesic drugs may provide inadequate analgesia and have side effects such as respiratory depression and bleeding. The inherent disadvantages of analgesic pharmacotherapy in children promoted interest in nerve blocking techniques for operative analgesia.

The maxillary nerve, the second division of the trigeminal nerve, leaves the cranial part of the face through the foramen rotundum, and then passes forward and laterally through the pterygopalatine fossa, at the bottom of the pterygomaxillary fossa, and reaches the floor of the orbit by the infra-orbital foramen. This sensory nerve supplies innervation of the lower eyelid, the upper lip, the skin between them, the roof of the mouth, and the palate. Bilateral infra-orbital nerve block is clearly inefficient for anesthesia of the posterior part of the palate (hard palate). The infrazygomatic route of the maxillary block, useful for trigeminal neuralgia, can present several risks such as penetration of the orbit or the skull and accidental maxillary artery puncture. The palatine nerve block could be efficient for analgesia following cleft palate repair, but the technique requires identifying the first molar, which is absent in infants. Finally, submucosal infiltration performed by the surgeon seems to alter surgical conditions. Maxillary nerve block using the suprazygomatic approach has demonstrated beneficial effects in adults for trigeminal neuralgia and limits the risks related to the procedure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
1 Year 至 9 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age between 1 and 9 years
  • Children scheduled for primary surgery for soft palate cleft or soft and hard palate clefts
  • Gender: both
  • ASA grade I - II.
  • Informed consent.

排除标准

  • Parent refusal
  • History of developmental delay or mental retardation, which will make observational pain intensity assessment difficult
  • Hypersensitivity to any local anesthetics
  • Bleeding diathesis
  • Children with co-morbid conditions like congenital heart disease, respiratory pathology and central nervous system disorders
  • Skin lesions or wounds at the puncture site of the proposed block

研究组 & 干预措施

with dexamethasone

Active Comparator

bilateral suprazygomatic maxillary nerve block will be performed with 1 mL of 0.5% bupivacaine was added to 0.1 mg.kg-1 dexamethasone and diluted to 2 mL with 0.9% saline.

干预措施: Dexamethasone (Drug)

with dexamethasone

Active Comparator

bilateral suprazygomatic maxillary nerve block will be performed with 1 mL of 0.5% bupivacaine was added to 0.1 mg.kg-1 dexamethasone and diluted to 2 mL with 0.9% saline.

干预措施: Bupivacaine (Drug)

without dexamethasone

Placebo Comparator

bilateral suprazygomatic maxillary nerve block will be performed with 1 mL of 0.5% bupivacaine alone and diluted to 2 mL with 0.9% saline.

干预措施: Bupivacaine (Drug)

结局指标

主要结局

Postoperative pain score

时间窗: baseline

pain in Faces, Legs, Activity, Cry, Consolability (FLACC) Each category is scored on the 0-2 scale which results in a total score of 0-10.

Assessment of Behavioral Score

时间窗: baseline

0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain

次要结局

  • The first-time requested analgesia .(24 hours)
  • The number of children required analgesia.(24 hours)
  • The total amount of analgesic requirements .(24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mark Wageh

Anaesthesia and ICU Resident

Assiut University

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