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

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ClinicalTrials.gov Identifier: NCT03261921
Recruitment Status : Completed
First Posted : August 25, 2017
Last Update Posted : August 25, 2017
Sponsor:
Information provided by (Responsible Party):
Amany Hassan Saleh, Cairo University

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Caudal Block Drug: Dexamethasone Drug: Dexmedetomidine Drug: Bupivacaine Phase 1

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description:

Sixty-three patients with ASA I-II aged from 1-6 years scheduled for hypospadias surgery in Abu El-Resh pediatric Hospital-Cairo university, were included in this prospective randomized double-blinded clinical study. Patients with 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 were excluded from the study.

Patients were randomly divided on the morning of surgery into three groups group I( dexamethasone 21 patients), Group II ( Dexmedetomidine 21 patients) and group III(Dexmedetomidine and dexamethasone 21 patients).

Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: The Patients allocated to study groups using computer generated random list & group assignment was sealed in sequentially numbered opaque envelopes that opened after induction of anesthesia.
Primary Purpose: Diagnostic
Official Title: Adjuncts to Caudal Block in Pediatrics
Actual Study Start Date : June 5, 2016
Actual Primary Completion Date : June 22, 2017
Actual Study Completion Date : July 7, 2017


Arm Intervention/treatment
Active Comparator: Dexamethasone group
In this group the patients received 0.5 ml/kg of bupivacaine 0.25% + (0.1 mg/kg dexamethazone) caudally.
Drug: Dexamethasone
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 Name: decadron

Drug: Bupivacaine
local anesthetic agent
Other Name: plain marcaine

Active Comparator: Dexmedetomidine group
In this group the Patients received 0.5 ml/kg of bupivacaine 0.25% + dexmedetomidine(1 mu/kg) caudally.
Drug: Dexmedetomidine
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 Name: precedex

Drug: Bupivacaine
local anesthetic agent
Other Name: plain marcaine

Active Comparator: Combination group
In this group the patients received 0.5 ml/kg of bupivacaine 0.25% + dexamethasone(0.1mg/kg) and dexmedetomidine (1 mu/kg) caudally.
Drug: Dexamethasone
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 Name: decadron

Drug: Dexmedetomidine
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 Name: precedex

Drug: Bupivacaine
local anesthetic agent
Other Name: plain marcaine




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 6 Years   (Child)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   males candidate for hypospadias surgery
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

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Responsible Party: Amany Hassan Saleh, principal investigator,MD of anesthesia and intensive care unit., Cairo University
ClinicalTrials.gov Identifier: NCT03261921     History of Changes
Other Study ID Numbers: N-43-2016
First Posted: August 25, 2017    Key Record Dates
Last Update Posted: August 25, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dexamethasone
Dexamethasone acetate
Dexmedetomidine
Bupivacaine
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents