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NCT Number: NCT02416063

Caudal Versus Intravenous Dexmedetomidine for Caudal Analgesia in Children

The aim of this prospective randomized double-blind study was to compare the analgesic efficacy and the side effects of dexmedetomidine (1 µg.kg-1) co-administered with bupivacaine for caudal analgesia or intravenously in children undergoing infra-umbilical surgery.

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Key information

Age range

1 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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 dexmedetomidine 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 bupivacaine in children undergoing infra-umbilical surgery.

75 children (ASAⅠorⅡ,aged 1-6 yr) undergoing infra-umbilical surgery 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 B-Dcau (n = 25): Caudal bupivacaine 0.25% 1ml/kg plus dexmedetomidine 1µg/kg and 10 ml normal saline i.v.;Group B-Div (n = 25): bupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg(10 ml)i.v.;Group B(n = 25): bupivacaine 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

  • Patients with American Society of Anesthesiologists (ASA) - I
  • Scheduled for lower abdominal and perineal surgery
  • Under general anesthesia

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
  • Children with uncorrected cardiac lesions
  • Children with heart block

Treatment and study plan

Caudal Dexmedetomidine

Drug

Drug:Caudal bupivacaine 0.25% 1ml/kg

Drug: Caudal dexmedetomidine 1µg/kg

Intravenous: 10 ml normal saline

sevoflurane Induction and maintenance of anesthesia

Other names: dexmedetomidine, Precedex

Intravenous dexmedetomidine

Drug

Drug:Caudal bupivacaine 0.25% 1ml/kg.

Drug:Intravenous dexmedetomidine1 μg /kg in a total volume of 10 ml

sevoflurane Induction and maintenance of anesthesia

Other names: precedex

Placebo

Drug

Drug:Caudal bupivacaine 0.25% 1ml/kg

Intravenous: Normal saline 10 ml

sevoflurane Induction and maintenance of anesthesia

Other names: normal saline

Primary outcomes

  1. Time to first analgesic requirement

    Time frame: 24 hours

    Time to first rescue medication. The time from end of surgery to the first requirement of postoperative analgesia,pain score ≥4

Secondary outcomes

  1. Postoperative behaviour scores

    Time frame: 2 hours

    behaviour score was recorded throughout the post-anesthesia care unit stay at 15-minute time intervals.

  2. Sevoflurane concentration

    Time frame: 1 hour

    Sevoflurane concentration required to maintain Bispectral Index (BIS) monitor reading between 40 and 60

  3. Blood pressure Perioperative blood pressure readings

    Time frame: 2 hours

    Perioperative blood pressure readings

  4. Heart Rate

    Time frame: 2 hours

    Perioperative heart rate readings

  5. the incidence of emergence agitation

    Time frame: 2 hours

    Participants will be followed for the duration of PACU stay, an expected average of 2 hours

  6. Postoperative pain scores

    Time frame: 24 hours

    postoperative pain score will be assessed over 24 hours

  7. Side effects

    Time frame: 24 hours

    side effects including nausea, vomiting and urinary retention and lower limb weakness

Sponsors and collaborators

Lead sponsor

University of Jordan

Other

Registry information

Official study title

Caudal Versus Intravenous Dexmedetomidine for Caudal Analgesia in Children: A Randomised Controlled Double Blind Study

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 14, 2015
Registry last updated
Apr 14, 2015

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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