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

Adjuncts to Caudal Block in Pediatrics

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03261921
Enrollment
63
Registered
2017-08-25
Start date
2016-06-05
Completion date
2017-07-07
Last updated
2017-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caudal Block

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

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.

Interventions

DRUGDexamethasone

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

DRUGDexmedetomidine

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

DRUGBupivacaine

local anesthetic agent

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, 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.

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).

Eligibility

Sex/Gender
MALE
Age
1 Years to 6 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Time of first request of analgesia12 hoursthe time from caudal block to the first time to analgesic needs
pain scores12 hoursthe modified objective pain score

Secondary

MeasureTime frameDescription
sedation score12 hoursramsay sedation score at the time of pain
heart rates(beat/minute)3 hours.Intra-operative recording
mean arterial pressure (mmhg)3 hoursIntra-operative recording

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026