Comparison of Peritonsillar Dexamethasone-bupivacaine and Bupivacaine Infiltration for Tonsillectomy Pain Relief in Children:a Randomized,Double Blind,Controlled Study.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Incidence of moderate/severe pain(>/= 4 of 10 Pain Scores)
研究概览
简要总结
Investigators compared in this study peritonsillar infiltration of bupivacaine %0.5 (n=40 participants) versus bupivacaine % 0.5 and dexamethasone (number 40participants ) before surgery for reduce posttonsillectomy pain.And control group (n= 40participants) participants received peritonsillar Nacl 0,9% .
详细描述
Bupivacaine hydrochloride amid structure,long acting local anesthetic. Dexamethasone has strong anti-inflammatory drug reduce postoperative pain and nause and vomiting.Preoperative iv dexamethasone is routinely using for reduce tonsillectomy pain.Lots of studies show that adding dexamethasone to local anesthetic at peripheral nerve block prolongs the analgesic effect.Also preoperative iv dexamethasone prolongs the analgesic effects of local anesthetic infiltration .
Post tonsillectomy pain still a serious problem ,it effects postoperative morbidity.Different medicine combination used to applies for peritonsillar infiltration and multimodal iv and oral medication to reduce posttonsillectomy pain.İn this study investigators will use iv dexamethasone for all participants and investigators hypothesis that adding dexamethasone to bupivacaine for peritonsillar infiltration will reduce postoperative pain scores , consumption of rescue analgesic ,patient and family satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Tonsillectomy surgery for recurrent tonsillitis Sleep disorder breathing
- •ExclusionCriteria:
- •Patients with active upper respiratory tract infection Patients with significant cognitive impairment Bupivacaine hypersensitivity Dexamethasone hypersensitivity Taking chronic systemic steroids
排除标准
- 未提供
研究组 & 干预措施
Nacl 0,9% (Control) group
Nacl 0,9% 3-5 ml separately two part for each tonsil before surgery
干预措施: Nacl 0,9 % (Drug)
Bupivacaine 0,5%
Bupivacaine 0.5% 1 mg/kg with in Nacl 0,9% 3-5 ml separately two part for each tonsil before surgery
干预措施: Bupivacaine 0.5% (Drug)
Bupivacaine 0,5% , Dexamethasone
Bupivacaine 0,5% 1 mg/kg,dexamethasone 0.5 mg/kg (max dosage 8mg) 3-5 ml separately two part for each tonsil before surgery
干预措施: Bupivacaine 0.5% , Dexamethasone (Drug)
结局指标
主要结局
Incidence of moderate/severe pain(>/= 4 of 10 Pain Scores)
时间窗: postoperative 7day .
Pain Scores will measure ; Face, Leg, Activity, Cry, Consolability score (FLACC) Interpreting the Score 0 Relaxed \& comfortable 1 - 3 = Mild discomfort 4 - 6 = Moderate pain 7 -10 = Severe pain or discomfort or both . 0 score is the best ,10 score is the worse score. 4 and up scores will considered to be the range to be treated .Pain score will measure at home ; Face Pain Scale 0 no pain 10 worse pain. Every day in the morning after phone call pain scores will ask patient/patient guardians. 4 and up scores will treated
次要结局
- Parents satisfaction(postop seven day)
- Side effects (nause,vomiting)(postop seven day)
- Rescue analgesic consumption at home(postop 2-3-5-6- 7. day)
- Rescue analgesic consumption at PACU (post-anaesthesia care unit)(At Pacu 1 hour)
- Rescue analgesic consumption first day at hospital(4,8,12,24 h at hospital in first postoperative day.)
研究者
Leyla Kılınc
Principal investigator
Sisli Hamidiye Etfal Training and Research Hospital