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Efficacy of Peritonsillar Dexmedetomidine Infiltration for Postadenotonsillectomy Pain

2013년 12월 11일 업데이트: Isin Gunes, TC Erciyes University
The purpose of the present study is the clinical assessment of the efficacy of preincisional peritonsillar infiltration of dexmedetomidine on postoperative pain relief in children undergoing adenotonsillectomy.

연구 개요

상세 설명

Background:Tonsillectomy is a common and painful procedure in children, often performed on an outpatient basis. Tonsillectomy is often associated with intraoperative bleeding and postoperative severe pain. Different methods such as drugs (nonsteroidal antiinflammatory drugs , opioids, corticosteroids ), adjustment of surgical technique and peroperative local anaesthetic infiltration have been used to reduce pain. It is known that pain after adenotonsillectomy or analgesic usage may lead to unwanted effects. For example, nonsteroidal antiinflammatory drugs may interfere with bleeding and opioids may cause respiratory depression, sedation or nausea and vomiting. There are some reported complications seen infiltrations of local anaesthetics into tonsillar and adenoid beds. No studies have assessed the effects of peritonsillar dexmedetomidine infiltration. Dexmedetomidine is a centrally acting sympatholytic agent that has intrinsic effect of regional anesthesia with amid anesthetic.Because of its analgesic and sedating activity, dexmedetomidine has been used previously as an nasal premedication in patients undergoing tonsillectomy, but its use, as a peritonsillar infiltration has not been evaluated. Dexmedetomidine is a highly selective alfa-2 adrenoreceptor agonist recently introduced to anesthesia practice producing dose-depended sedation, anxiolysis, and analgesia (involving spinal and supraspinal sites), without respiratory depression. Also Alpha-2 adrenergic agonists have peripheral analgesic effects. Therefore, this study was designed to compare the effects of preincisional, dexmedetomidine 2µg/kg peritonsillar infiltration by peritonsillar normal saline grup on intraoperative bleeding and hemodynamics, postoperative recovery including pain, sedation, nausea and vomiting in pediatric patients undergoing adenotonsillectomy, and the recording of any adverse effects that might develop during the 24-h study period.

Methods: Seventy patient were randomized into two groups: group S peritonsillar 2ml normal saline (1 ml per tonsil), group D 2mikro gram/kg dexmedetomidine in 2 ml normal saline (1 ml per tonsil).

After institutional Ethics Committee approval and parents written consent, 70 children aged 3-9 years, American Society of Anesthesiologists 1-2 status, scheduled for adenotonsillectomy were enrolled in this randomized, prospective, triple-blind clinical study. Children with systemic disease, metabolic and endocrin disorders, growth developmental and motor-mental retardation, those who had a history of allergy to any of the study drugs, peritonsillar abscess, hypertension, psychiatric and epileptic disorders, chronic pain syndrome, and those who received analgesics within 24 h prior to surgery were excluded from study.

The children were unpremedicated. Anaesthesia was induced with sevoflurane 8% and nitrous oxide 70% in oxygen or intravenous induction with propofol (2,5-3 mg/kg). After induction rocuronium 0,6 mg/kg was administered for muscle relaxation and fentanyl 1 µg/kg before tracheal intubation. Anaesthesia was maintained with sevoflurane 2-3% and nitrous oxide 30% in oxygen. After intubation children were randomized into two groups:Group D 2µg/kg dexmedetomidine in 2 ml normal saline (1 ml per tonsil), Group S peritonsillar 2ml normal saline (1 ml per tonsil) via peritonsillar infiltration. For the infiltration, all injections were performed through the tonsillar capsule and anterior plica. After the infiltration, a minimum of 3 min was allowed for the onset of action of dexmedetomidine before adenotonsillectomy. Adenotonsillectomy was performed with snare technic by the same surgeon in all cases. Heart rate, arterial pressure and oxygen saturations (SpO2) were recorded at 10 min interval during operation.All patients received metoclopropamide 0,2 mg/kg i.v. before end of the surgery. After extubation the patients were taken to the postanesthesia care unit where an anesthetist and nurses who were unaware of the study drug observed the patients.

Modified Hannallah pain scale (observational pain scores-OPS), nausea, vomiting, bleeding, rescue analgesia, sedation and Aldrete scores were recorded on arrival in the postanesthesia care unit, at 15th, 30th, 60th, 90th and 120th min. Patient with OPS scores >4, for a patient request for pain medication, received 1mg/kg Tramadol drop as supplementary analgesia. The first analgesic requirement time recorded. Children vomiting twice or more in PACU received additional antiemetic drug (metoclopropamide 0,2 mg/kg i.v.). Agitation was measured with Pediatric anesthesia emergence delirium scale. Patients with an Aldrete score of 9 were transferred to the postoperative surgical ward.

Pain, nausea and vomiting, bleeding and sedation were assessed in the postoperative surgical ward at0,2,4,6h follow-up by the nurses who were trained fort he use of scores involved. Analgesic requirement were recorded. Pain was measured at rest and with swallowing. All patients were discharged at the and of the day and stayed home at night. Before the discharge, parents were given a prescription for acetaminophen (15 mg/kg oral dose) to be given when needs to analgesia. Postoperative pain during the first 24 h was assessed using a four-point scale: 0=no pain, 1=mild pain, 2=moderate pain, 3=severe pain by questioning their parents. Patients were interviewed on the day after surgery to asses the postoperative pain, vomiting, bleeding and rescue analgesia. Family satisfaction was assessed as follows: 1=poor; 2=good; 3=perfect.

연구 유형

중재적

등록 (실제)

71

단계

  • 4단계

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

3년 (어린이)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

children aged 3-9 years American Society of Anesthesiologists 1-2 status, scheduled for adenotonsillectomy

Exclusion Criteria:

Children with systemic disease, metabolic and endocrin disorders, growth developmental and motor-mental retardation, those who had a history of allergy to any of the study drugs, peritonsillar abscess, hypertension, psychiatric and epileptic disorders, chronic pain syndrome, and those who received analgesics within 24 h prior to surgery were excluded from study.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Dexmedetomidine
Group S peritonsillar 2ml normal saline (1 ml per tonsil) via peritonsillar infiltration.
2µg/kg dexmedetomidine in 2 ml normal saline (1 ml per tonsil),
다른 이름들:
  • 선행
위약 비교기: Normal saline, postoperative pain
Group S peritonsillar 2ml normal saline (1 ml per tonsil) via peritonsillar infiltration.
2µg/kg dexmedetomidine in 2 ml normal saline (1 ml per tonsil),
다른 이름들:
  • 선행

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
post adenotonsillectomy pain
기간: 24 hours

Modified Hannallah pain scale, nausea, vomiting, bleeding, rescue analgesia, sedation and Aldrete scores were recorded on arrival in the postanesthesia care unit, at 15th, 30th, 60th, 90th and 120th min. Patient with pain scores >4, for a patient request for pain medication, received 1mg/kg Tramadol drop as supplementary analgesia. The first analgesic requirement time recorded. Agitation was measured with Pediatric anesthesia emergence delirium scale. Patients with an Aldrete score of 9 were transferred to the postoperative surgical ward.

Pain, nausea and vomiting, bleeding and sedation were assessed in the postoperative surgical ward. Analgesic requirement were recorded. Pain was measured at rest and with swallowing. All patients were discharged at the end of the day and stayed home at night. Postoperative pain during the first 24 h was assessed using a four-point scale. Patients were interviewed on the day after surgery to ases.

24 hours

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2013년 9월 1일

기본 완료 (실제)

2013년 12월 1일

연구 완료 (실제)

2013년 12월 1일

연구 등록 날짜

최초 제출

2013년 12월 2일

QC 기준을 충족하는 최초 제출

2013년 12월 11일

처음 게시됨 (추정)

2013년 12월 17일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2013년 12월 17일

QC 기준을 충족하는 마지막 업데이트 제출

2013년 12월 11일

마지막으로 확인됨

2013년 9월 1일

추가 정보

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Dexmedetomidine에 대한 임상 시험

구독하다