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临床试验/NCT01638052
NCT01638052已完成2 期

Great Auricular Nerve Block for Children Undergoing Tympanomastoid Surgery: Does the Addition of Clonidine Increase the Duration of Postoperative Analgesia?

Ann & Robert H Lurie Children's Hospital of Chicago1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2006年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
56
试验地点
1
主要终点
Average Observer-Rated Patient Pain Scores

研究概览

简要总结

The investigators goal is to determine the efficacy and duration of analgesia with the addition of Clonidine, an alpha-2 agonist, to local anesthetic blockade using bupivacaine, of the great auricular nerve in children undergoing tympanomastoid surgery.

详细描述

The surgical anesthesia during the operative procedure will be maintained using volatile anesthetics. No prophylactic dexamethasone or ondansetron would be provided to any patients in either group. Anesthesia will be discontinued at the end of the procedure and the patient will be extubated once standard extubation criteria have been met. Patients will be then taken to the postoperative recovery room where they will be evaluated for pain and discomfort by a blinded observer using the CHIPPS (Children and Infants Postoperative Pain Scale). If two consecutive pain scores at 5 minute intervals is >6, they will be rescued with incremental doses of 0.05 mg/kg of intravenous morphine required to reach a score of <6. The number of rescue doses as well as the pain scores will be documented. These patients will be also observed for the presence of nausea/vomiting. Any patient who vomits more than two times will be rescued with ondansetron 0.1 mg/kg intravenously. All patients will be continued to be evaluated in the 23 hour unit. Pain and side effects will be assessed for the next 6 hours or until discharge from the 23 hour observation facility. Standard doses of acetaminophen with codeine will be provided for pain relief in the 23 hour observational unit, as well as on discharge. The number of doses of acetaminophen with codeine will be recorded. Time to discharge from the hospital will also be noted. A questionnaire designed to address parent/patient satisfaction will be utilized and will allude to the need for rescue analgesia and the need for any other additional analgesics provided. The use of any additional rescue pain medication will be provided to the families at the time of discharge. A follow-up phone call will be made in 24 hours to note the information provided on the questionnaire.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
1 Year 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • age 1-18 years
  • tympanomastoid surgery (cochlear implant, mastoidectomy, cholesteatoma surgery)
  • ASA I, II
  • informed consent and assent obtained

排除标准

  • allergic to local anesthestic
  • taking chronic aspirin or Ibuprofen therapy
  • history of clinically important renal, hepatic, respiratory, cardiac, or neurological conditions
  • Patients who have cardiovascular surgery other than an atrial septal defect or a ventricular septal defect, or who have undergone complete corrective intracardiac repair of congenital heart disease.
  • Informed consent not obtained
  • Patients expected to receive dexamethasone or ondansetron intra-operative

研究组 & 干预措施

0.25% Bupivacaine + Clonidine

Experimental

These are not two separate drugs, but a mixture of Bupivacaine and Clonidine.

干预措施: 0.25% Bupivacaine + Clonidine (Drug)

结局指标

主要结局

Average Observer-Rated Patient Pain Scores

时间窗: 60 minutes

Patients will be observed with behaviors rated at regular time intervals using the CHIPPS (Children and Infants Postoperative Pain Scale) pain survey. The CHIPPS scale values range from a minimum of 0 (no pain, better outcome) to a maximum of 10 (worst pain, worse outcome).

次要结局

  • Number of Participants With Nausea/Vomiting(24 hours)
  • Number of Participants Requiring Use of Rescue Analgesic Medication in the Initial 24 Hours Postoperatively(24 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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