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

Phase 1

Completed

• Conditions: Caudal Block
• Interventions: Drug: Dexmedetomidine; Drug: Dexamethasone; Drug: Bupivacaine

• Registration Number: NCT03261921
• Lead Sponsor: 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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2016-06-05
• Primary Completion: 2017-06-22
• Study Completion: 2017-07-07
• Status Verified: 2017-08
• Study First Submitted: 2017-08-07
• Study First Submitted QC: 2017-08-22
• Last Update Submitted: 2017-08-22
• Study First Posted: 2017-08-25
• Last Update Posted: 2017-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 63

Inclusion Criteria

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine group	Dexmedetomidine	In this group the Patients received 0.5 ml/kg of bupivacaine 0.25% + dexmedetomidine(1 mu/kg) caudally.
Dexamethasone group	Dexamethasone	In this group the patients received 0.5 ml/kg of bupivacaine 0.25% + (0.1 mg/kg dexamethazone) caudally.
Dexmedetomidine group	Bupivacaine	In this group the Patients received 0.5 ml/kg of bupivacaine 0.25% + dexmedetomidine(1 mu/kg) caudally.
Combination group	Dexamethasone	In this group the patients received 0.5 ml/kg of bupivacaine 0.25% + dexamethasone(0.1mg/kg) and dexmedetomidine (1 mu/kg) caudally.
Dexamethasone group	Bupivacaine	In this group the patients received 0.5 ml/kg of bupivacaine 0.25% + (0.1 mg/kg dexamethazone) caudally.
Combination group	Dexmedetomidine	In this group the patients received 0.5 ml/kg of bupivacaine 0.25% + dexamethasone(0.1mg/kg) and dexmedetomidine (1 mu/kg) caudally.
Combination group	Bupivacaine	In this group the patients received 0.5 ml/kg of bupivacaine 0.25% + dexamethasone(0.1mg/kg) and dexmedetomidine (1 mu/kg) caudally.

Primary Outcome Measures

Name	Time	Method
Time of first request of analgesia	12 hours	the time from caudal block to the first time to analgesic needs
pain scores	12 hours	the modified objective pain score

Secondary Outcome Measures

Name	Time	Method
sedation score	12 hours	ramsay sedation score at the time of pain
heart rates(beat/minute)	3 hours.	Intra-operative recording
mean arterial pressure (mmhg)	3 hours	Intra-operative recording