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NCT Number: NCT03261921

Caudal Combination of Dexamethasone and/or Dexmedetomidine to Bupivacaine in Pediatric Hypospadias Surgery

One of the most commonly used regional anesthetic techniques in pediatric surgeries is the caudal epidural block. Its main disadvantage remains the short duration of action. Hence, different additives have been used. Dexmedetomidine as an additive to the local anesthetic bupivacaine in caudal epidural analgesia prolongs the duration of postoperative analgesia so is dexamethasone. The investigators aimed to study the effect of combining both additives in the duration of analgesia, decreasing side effects and decreasing anesthetic doses

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Key information

Conditions

Caudal Block

Age range

1 year–6 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

About this study

Sixty three children scheduled for hypospadias randomized into 3 groups. Group I (n=21) (dexamethasone 0.1mg/kg+ 0.5ml/kg bupivacaine 0.25%), group II(n=21)( dexmedetomidine 0.01ug/kg+ 0.5ml/kg bupivacaine 0.25%)and groupIII(n=21)(dexamethasone0.1mg/kg+dexmedetomidine0.01ug/kg +0.5ml/kg bupivacaine 0.25%).intraoperative and postoperative hemodynamics were recorded. In PACU, MOPS scores and sedation scores were recorded at 30min,1,2,3,6and 12hrs. Also the time of first analgesic request was recorded.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

1 - ASA I-II 2- Males only 3- Children aged from 1-6 years 4- Children scheduled for hypospadias surgery

Exclusion criteria

  • Contraindication to caudal anesthesia.
  • cardiovascular diseases.
  • drug allergy.
  • Type I diabetes.
  • Clotting disorders.
  • Mentally retarded children or those whose families did not approve inclusion in the study

Treatment and study plan

Dexamethasone

Drug

Dexamethasone is used peri -operatively mainly to prevent nausea and vomiting. Also epidural administration of dexamethasone prolong the postoperative analgesia and reduce analgesic needs

Other names: decadron

Dexmedetomidine

Drug

Dexmedetomidine is an alpha 2 agonist which has sedative ,analgesic, opioid sparing effect and was proved to prolong the duration of postoperative analgesia when added to local anesthetics

Other names: precedex

Bupivacaine

Drug

local anesthetic agent

Other names: plain marcaine

Primary outcomes

  1. Time of first request of analgesia

    Time frame: 12 hours

    the time from caudal block to the first time to analgesic needs

  2. pain scores

    Time frame: 12 hours

    the modified objective pain score

Secondary outcomes

  1. sedation score

    Time frame: 12 hours

    ramsay sedation score at the time of pain

  2. heart rates(beat/minute)

    Time frame: 3 hours.

    Intra-operative recording

  3. mean arterial pressure (mmhg)

    Time frame: 3 hours

    Intra-operative recording

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Adjuncts to Caudal Block in Pediatrics

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 25, 2017
Registry last updated
Aug 25, 2017

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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