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

Cairo University (CU)

Status and phase: Completed; Phase 1

Conditions: Caudal Block

Treatments: Drug: Dexmedetomidine; Drug: Dexamethasone; Drug: Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03261921

N-43-2016

Details and patient eligibility

About

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

Full 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.

Enrollment: 63 patients

Sex: Male

Ages: 1 to 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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63 participants in 3 patient groups

Dexamethasone group

Active Comparator group

Description:

In this group the patients received 0.5 ml/kg of bupivacaine 0.25% + (0.1 mg/kg dexamethazone) caudally.

Treatment:

Drug: Bupivacaine

Drug: Dexamethasone

Dexmedetomidine group

Active Comparator group

Description:

In this group the Patients received 0.5 ml/kg of bupivacaine 0.25% + dexmedetomidine(1 mu/kg) caudally.

Treatment:

Drug: Bupivacaine

Drug: Dexmedetomidine

Combination group

Active Comparator group

Description:

In this group the patients received 0.5 ml/kg of bupivacaine 0.25% + dexamethasone(0.1mg/kg) and dexmedetomidine (1 mu/kg) caudally.

Treatment:

Drug: Bupivacaine

Drug: Dexamethasone

Drug: Dexmedetomidine