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

Assiut University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Pain, Postoperative

Treatments: Drug: Dexmedetomidine + Magnesium Sulphate + Bupivacaine; Drug: Magnesium Sulphate; Drug: Bupivacaine; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT02487355

IRB000087123

Details and patient eligibility

About

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.

Full description

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Enrollment: 120 estimated patients

Sex: All

Ages: 6 months to 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 4 patient groups

group (MG)

Active Comparator group

Description:

Magnesium sulfate 50 mg add to 1 ml/kg of 0.25%of bupivacaine

Treatment:

Drug: Magnesium Sulphate

group (D)

Active Comparator group

Description:

Dexmedetomidine 1 μg/ kg to add to 1ml/kg of 0.25%of bupivacaine

Treatment:

Drug: Dexmedetomidine

group (MD)

Active Comparator group

Description:

50 mg magnesium sulfate and Dexmedetomidine 1 μg/ kg to add to 1ml/kg of 0.25%of bupivacaine

Treatment:

Drug: Dexmedetomidine + Magnesium Sulphate + Bupivacaine

group (C)

Active Comparator group

Description:

1ml/kg of 0.25%of bupivacaine + 1 ml of normal saline

Treatment:

Drug: Bupivacaine