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

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT03261921
Collaborator
(none)
63
Enrollment
3
Arms
13
Actual Duration (Months)

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
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).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 :
Jun 5, 2016
Actual Primary Completion Date :
Jun 22, 2017
Actual Study Completion Date :
Jul 7, 2017

Arms and Interventions

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 Names:
  • decadron

    • Drug: Bupivacaine
    local anesthetic agent
    Other Names:
  • 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 Names:
  • precedex

    • Drug: Bupivacaine
    local anesthetic agent
    Other Names:
  • 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 Names:
  • 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 Names:
  • precedex

    • Drug: Bupivacaine
    local anesthetic agent
    Other Names:
  • plain marcaine

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Time of first request of analgesia [12 hours]

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

    2. pain scores [12 hours]

      the modified objective pain score

    Secondary Outcome Measures

    1. sedation score [12 hours]

      ramsay sedation score at the time of pain

    2. heart rates(beat/minute) [3 hours.]

      Intra-operative recording

    3. mean arterial pressure (mmhg) [3 hours]

      Intra-operative recording

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 6 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Cairo University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Amany Hassan Saleh, principal investigator,MD of anesthesia and intensive care unit., Cairo University
    ClinicalTrials.gov Identifier:
    NCT03261921
    Other Study ID Numbers:
    • N-43-2016
    First Posted:
    Aug 25, 2017
    Last Update Posted:
    Aug 25, 2017
    Last Verified:
    Aug 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Dexamethasone
    Dexmedetomidine
    Bupivacaine

    Study Results

    No Results Posted as of Aug 25, 2017