Pediatric Caudal Dexmedetomidine Enhances Postoperative Analgesia of Magnesium Sulphate in Lower Abdominal Surgeries

Phase 2

• Conditions: Pain, Postoperative
• Interventions: Drug: Dexmedetomidine + Magnesium Sulphate + Bupivacaine; Drug: Bupivacaine; Drug: Magnesium Sulphate; Drug: Dexmedetomidine

• Registration Number: NCT02487355
• Lead Sponsor: Assiut University

Brief Summary

The study will conduct to compare the efficacy of Magnesium sulphate \& dexmedetomidine used as adjuvants to bupivacaine in caudal block to provide intra-operative anesthesia as well as post -operative analgesia in pediatric patients.

Detailed Description

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Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-06-29
• Study First Submitted QC: 2015-06-30
• Study First Posted: 2015-07-01
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-25
• Last Update Posted: 2017-09-26
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Healthy male and female children, ASA I and II,Aged 6 months to 6 years, , undergoing elective surgical procedures expected to last more than 90 min, and scheduled to receive general anesthesia combined with caudal extradural block

Exclusion Criteria

• Allergy to local anesthetics,coagulation disorders, infection at site of injection, anatomic abnormalities and congenital anomalies like spina bifid, ASA III or higher, Parental refusal and the current use of Calcium Channel Blockers or Medication that may affect the neurologic system

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group (MD)	Dexmedetomidine + Magnesium Sulphate + Bupivacaine	50 mg magnesium sulfate and Dexmedetomidine 1 μg/ kg to add to 1ml/kg of 0.25%of bupivacaine
group (C)	Bupivacaine	1ml/kg of 0.25%of bupivacaine + 1 ml of normal saline
group (MG)	Magnesium Sulphate	Magnesium sulfate 50 mg add to 1 ml/kg of 0.25%of bupivacaine
group (D)	Dexmedetomidine	Dexmedetomidine 1 μg/ kg to add to 1ml/kg of 0.25%of bupivacaine

Primary Outcome Measures

Name	Time	Method
Time to first analgesic requirement	24 hours	The time from end of surgery to the first requirement of postoperative analgesia

Secondary Outcome Measures

Name	Time	Method
Postoperative sedation scores	24 hours	Level of sedation was recorded throughout the post-anesthesia care unit stay at 15-minute time intervals

Trial Locations

Locations (1)

Assiut Univeristy Hospital; 🇪🇬 Assiut, Egypt