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Clinical Trials/NCT03261921
NCT03261921
Completed
Phase 1

Adjuncts to Caudal Block in Pediatrics

Cairo University0 sites63 target enrollmentJune 5, 2016

Overview

Phase
Phase 1
Intervention
Dexamethasone
Conditions
Caudal Block
Sponsor
Cairo University
Enrollment
63
Primary Endpoint
Time of first request of analgesia
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 5, 2016
End Date
July 7, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Factorial
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Amany Hassan Saleh

principal investigator,MD of anesthesia and intensive care unit.

Cairo University

Eligibility 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

  • 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

Arms & Interventions

Dexamethasone group

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

Intervention: Dexamethasone

Dexamethasone group

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

Intervention: Bupivacaine

Dexmedetomidine group

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

Intervention: Dexmedetomidine

Dexmedetomidine group

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

Intervention: Bupivacaine

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.

Intervention: Dexamethasone

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.

Intervention: Dexmedetomidine

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.

Intervention: Bupivacaine

Outcomes

Primary Outcomes

Time of first request of analgesia

Time Frame: 12 hours

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

pain scores

Time Frame: 12 hours

the modified objective pain score

Secondary Outcomes

  • sedation score(12 hours)
  • heart rates(beat/minute)(3 hours.)
  • mean arterial pressure (mmhg)(3 hours)

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