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

Pain, Postoperative Clinical Trial

— JASayed  

Official title:

Pediatric Caudal Epidural Dexmedetomidine Enhances Postoperative Analgesia of Magnesium Sulphate and Quality of Caudal Anesthesia in Lower Abdominal Surgeries

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02487355
• Other study ID #: IRB000087123
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: June 29, 2015
• Last updated: September 25, 2017
• Start date: May 2015
• Est. completion date: December 2017

Study information

• Verified date: September 2017
• Source: Assiut University
• Contact: Jehan A Sayed, MD
• Phone: +2 01006253939
• Email: jehan.alloul[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Dexmedetomidine
Dexmedetomidine 1 µg/ kg
• Magnesium Sulphate
Magnesium Sulphate 50 mg
• Bupivacaine
1ml/kg of 0.25%of bupivacaine
• Dexmedetomidine + Magnesium Sulphate + Bupivacaine
Dexmedetomidine 1 µg/ kg + Magnesium Sulphate 50 mg + 1ml/kg of 0.25%of bupivacaine

Locations

Country	Name	City	State
Egypt	Assiut Univeristy Hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first analgesic requirement	The time from end of surgery to the first requirement of postoperative analgesia	24 hours
Secondary	Postoperative sedation scores	Level of sedation was recorded throughout the post-anesthesia care unit stay at 15-minute time intervals	24 hours