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

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

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02487355
Acronym
JASayed
Enrollment
120
Registered
2015-07-01
Start date
2015-05-31
Completion date
2017-12-31
Last updated
2017-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

Keywords

dexmedetomidine, magnesium sulphate

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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Interventions

DRUGDexmedetomidine

Dexmedetomidine 1 μg/ kg

DRUGMagnesium Sulphate

Magnesium Sulphate 50 mg

DRUGBupivacaine

1ml/kg of 0.25%of bupivacaine

DRUGDexmedetomidine + Magnesium Sulphate + Bupivacaine

Dexmedetomidine 1 μg/ kg + Magnesium Sulphate 50 mg + 1ml/kg of 0.25%of bupivacaine

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Months to 6 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Time to first analgesic requirement24 hoursThe time from end of surgery to the first requirement of postoperative analgesia

Secondary

MeasureTime frameDescription
Postoperative sedation scores24 hoursLevel of sedation was recorded throughout the post-anesthesia care unit stay at 15-minute time intervals

Countries

Egypt

Contacts

Primary ContactJehan A Sayed, MD
jehan.alloul@yahoo.com+2 01006253939
Backup Contactmohamed amir, MD
dr.amir63@yahoo.com+01005689353

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026