|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT03460041 |
|
Date of registration:
|
26/02/2018 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Caudal Dexmetedomedine Versus Magnesium in Orthopedic Pediatric Surgeries
|
|
Scientific title:
|
Caudal Dexmetedomedine Versus Magnesium in Orthopedic Pediatric Surgeries |
|
Date of first enrolment:
|
December 1, 2017 |
|
Target sample size:
|
36 |
|
Recruitment status: |
Unknown status |
|
URL:
|
https://clinicaltrials.gov/show/NCT03460041 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Care Provider, Investigator).
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
Egypt
| | | | | | | |
|
Contacts
|
|
Name:
|
Cairo University |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
Hagar Hassanein Refaee, Assistant lecturer |
|
Address:
|
|
|
Telephone:
|
01063949855 |
|
Email:
|
bibo_gogo12@yahoo.Com |
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Age between 1 - 7 years old.
- American Society of Anesthesiologist (ASA) physical status class I- II.
- Patients scheduled for infra-umbilical orthopedic surgeries.
Exclusion Criteria:
- Patients with known allergy to the study drugs
- Suspected coagulopathy.
- Infection at the site of caudal block.
- History of developmental delay or neuromuscular disorders.
- Skeletal deformities.
- Patients on magnesium therapy
Age minimum:
1 Year
Age maximum:
7 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Pain in Pediatric Patients
|
|
Intervention(s)
|
|
Drug: Magnesium Sulfate
|
|
Drug: Dexmetedomedine
|
|
Drug: Bupivacaine
|
|
Primary Outcome(s)
|
|
Postoperative pain
[Time Frame: 12 hours]
|
|
Secondary ID(s)
|
|
N-59-2017
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|