Clinical Trial: Caudal Versus Intravenous Dexmedetomidine for Supplementation of Caudal Analgesia in Children

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Double-blind Randomized Controlled Trial of Caudal Versus Intravenous Dexmedetomidine for Supplementation of Caudal Analgesia in Children

Brief Summary: The purpose of this study is to compare the effects of caudal dexmedetomidine with intravenous dexmedetomidine on caudal levobupivacaine analgesia in children undergoing lower abdominal surgeries.

Detailed Summary:

Single shot caudal epidural block is one of the most widespread technique for pediatric pain management after infraumbilical surgical procedures.However, in a significant proportion of patients, despite good initial analgesia from a caudal block with local anesthetic, pain develops after the block resolves.

Dexmedetomidine is used increasingly in pediatric anesthesia practice to prolong the duration of action of caudal block with a local anesthetic agent.But which route of administration of clonidine is the most beneficial remains unknown.

The investigators performed prospective randomized double-blind study to compare the effects of caudal dexmedetomidine with intravenous dexmedetomidine on postoperative analgesia after caudal levobupivacaine for inguinal herniorrhaphy or orchidopexy surgery.

90 children (ASAⅠorⅡ,aged 2-5 yr) undergoing unilateral orchiopexy or inguinal herniorrhaphy were included in this study. Anesthesia was induced with sevoflurane via a facemask, followed by placement of a laryngeal mask airway. Anesthesia was maintained with sevoflurane 2-3% in oxygen-air.Then,caudal block was applied. Patients were randomly assigned in three groups. Group Cau-DEX (n = 30): Caudal Levobupivacaine 0.25% 1ml/kg plus dexmedetomidine 1µg/kg and 10 ml normal saline i.v.;Group IV-DEX(n = 30): Levobupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg(10 ml)i.v.;Group Placebo(n = 30): Levobupivacaine 0.25% and 10 ml normal saline intravenous.


Sponsor: Yao Yusheng

Current Primary Outcome: Time to first rescue medication [ Time Frame: From the administration of the caudal block to the first registration of a CHIPPS scores≥4,assessed up to 24h ]

the Children and Infants Postoperative Pain Scale (CHIPPS)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • the number of patients not requiring rescue analgesia [ Time Frame: After surgery,up to 24h ]
    the quality of postoperative pain control
  • the sedation score [ Time Frame: After surgery, every 15min for the first 2 h, every 30min for the next 2h, hourly for the next 4h ]
    sedation was assessed using the Modified Ramsay Sedation Score
  • Residual motor block [ Time Frame: After awake,participants will be followed every 30min for the first 2h, hourly for the next 4h ]
    the degree of motor blockade was assessed using a modified Bromage scale
  • the incidence of emergence agitation [ Time Frame: Participants will be followed for the duration of PACU stay, an expected average of 2 hours ]
    The incidence of emergence agitation was evaluated by the Pediatric Anesthesia Emergence Delirium Scale(PAED)
  • side effects [ Time Frame: From the administration of the caudal block until the end of study period, assessed up to postoperative 24h ]
    side effects including bradycardia, hypotension, hypoxemia, nausea, vomiting and urinary retention
  • Pain intensity [ Time Frame: after surgery, 30min for first 4h, hourly for the next 4h and thereafter every 2h,assessed up to 24h ]
    Participants will be assessed with Children and Infants Postoperative Pain Scale (CHIPPS)


Original Secondary Outcome: Same as current

Information By: Fujian Provincial Hospital

Dates:
Date Received: October 2, 2012
Date Started: October 2012
Date Completion:
Last Updated: May 7, 2014
Last Verified: May 2014