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NCT Number: NCT01701778

Caudal Versus Intravenous Dexmedetomidine for Supplementation of Caudal Analgesia in Children

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA status I-II
  • aged 2-5 yr
  • Undergoing unilateral orchiopexy/inguinal hernia repair

Exclusion criteria

  • Hypersensitivity to any local anesthetics
  • Patient has history of allergy, intolerance, or reaction to dexmedetomidine
  • Infections at puncture sites
  • Bleeding diathesis
  • Preexisting neurological disease
  • Diabetes mellitus
  • Children with uncorrected cardiac lesions
  • Children with heart block or liver impairment

Treatment and study plan

Caudal Dexmedetomidine

Drug

Caudal: Levobupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg

Intravenous: 10 ml normal saline

Other names: Precedex

Intravenous dexmedetomidine

Drug

Caudal: Levobupivacaine 0.25% 1ml/kg

Intravenous: dexmedetomidine 1µg/kg

Other names: Precedex

Placebo

Drug

Caudal: Levobupivacaine 0.25% 1ml/kg

Intravenous: 10 ml normal saline

Other names: Levobupivacaine

Sevoflurane

Drug

Induction and maintain anaesthesia

Primary outcomes

  1. 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)

Secondary outcomes

  1. the number of patients not requiring rescue analgesia

    Time frame: After surgery,up to 24h

    the quality of postoperative pain control

  2. 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

  3. 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

  4. 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)

  5. 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

  6. 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)

Sponsors and collaborators

Lead sponsor

Yao Yusheng

Other

Collaborators

  • West China Hospital

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Oct 5, 2012
Registry last updated
Nov 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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