- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03460041
Caudal Dexmetedomedine Versus Magnesium in Orthopedic Pediatric Surgeries
This study will be performed in Abo Elreesh Pediatric Hospital / Cairo University after obtaining approval by the University Ethics Committee, and a written informed consent from the parents or guardians.
Thirty six patients will be randomly assigned using an online randomization program (http://www.randomizer.org) and the sealed envelope method into three groups: Group D (n=12): Dexmetedomidine group. 0.5 ml of dexmetedomidine (2 μg/kg) added to bupivacaine, Group M (n=12) : Magnesium group.0.5 ml of magnesium sulphate (50 mg) added to bupivacaine, Group C (n=12) :Control group.bupivacaine 0.25% diluted in normal saline with total volume of 1 ml/kg.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
History regarding previous anesthesia, surgery, any significant medical illness, medications and allergy will be taken for all children who will be enrolled in the study. Complete physical examination and airway assessment will be done. Hemoglobin percentage, blood sugar and coagulation profile will be investigated preoperatively Sedation will be done by giving midazolam (0.2 mg/kg IM).On arrival to the operating room all patients will be monitored by 5 leads electrocardiography (ECG), automated non-invasive blood pressure monitoring (NIBP), and pulse oximetery.
Inhalational induction of anesthesia will be achieved by 8% sevoflurane in 100% oxygen and an appropriate-sized cannula will be inserted. Endotracheal intubation will be performed after which sevoflurane concentration will be reduced to 3%. After hemodynamic stabilization, caudal block will be performed by using beveled needle 18-23 G in the lateral decubitus position by using the loss of resistance technique. The study solutions will be injected caudally slowly with repetitive intermittent aspiration by an anesthesiologist blinded to the test drugs. The inhaled concentration of sevoflurane will be adjusted to achieve hemodynamic changes less than 30% of the preoperative values
Recorded Parameters for the study:
Intraoperative hemodynamic: heart rates (beats/minutes), mean arterial blood pressure (mmHg) after stabilization, before skin incision and every 15 minutes till the end of surgery.
Sedation score: Sedation will be monitored after PACU arrival using Ramsay score with its 0-6 score range.
Pain score (FLACC score) with its 0-10 score range, each patient pain intensity will be assessed at the end of surgery and 12 hours postoperatively.
Time of rescue analgesia (from the time of caudal injection to the time at which FLACC score 4 or more) will be recorded.
Complication secondary to test drugs in the form of toxicity like postoperative nausea and vomiting, respiratory depression, hematoma, bradycardia (HR <80 BPM) and hypotension (SBP <70 mmhg+ age in years * 2) and complication secondary to caudal block; infection, hematoma and pain at the site of injection will be recorded.
Total doses of rescue drugs will be calculated for each group.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Hagar Hassanein Refaee, Assistant lecturer
- Phone Number: 01063949855
- Email: bibo_gogo12@yahoo.Com
Study Contact Backup
- Name: Mai Ahmed Aly, Lecturer
Study Locations
-
-
-
Cairo, Egypt
- Recruiting
- Cairo University faculty
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Control
|
Caudal bupivacaine for pain management
|
Active Comparator: Magnesium
|
caudal magnesium sulphate added to bupivacaine for pain management
|
Active Comparator: Dexmetedomedine
|
Caudal dexmetedomedine added to bupivacaine for pain management
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative pain
Time Frame: 12 hours
|
Comparing duration of analgesia between caudal magnesium and caudal dexmetedomedine using flacc score
|
12 hours
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anticonvulsants
- Anesthetics, Local
- Calcium-Regulating Hormones and Agents
- Reproductive Control Agents
- Calcium Channel Blockers
- Tocolytic Agents
- Bupivacaine
- Magnesium Sulfate
Other Study ID Numbers
- N-59-2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain in Pediatric Patients
-
American Regent, Inc.Not yet recruiting
-
Prince of Songkla UniversityUnknownThe Predictors of Difficult Intubation in Pediatric PatientsThailand
-
University of North Carolina, Chapel HillRecruitingOff Label Use of Medications in Pediatric PatientsUnited States
-
Clear Guide MedicalNational Institutes of Health (NIH); Children's National Research InstituteUnknownClinical Procedures Which Require Vessel Cannulations in Pediatric Patients
-
Minia UniversityCompletedUnilateral TAP Block in Pediatric Patients Undergoing Lower Abdominal SurgeryEgypt
-
Sakarya UniversityEge UniversityCompletedAssessment of Oral Health Status of Patients in Pediatric Intensive Care UnitsTurkey
-
Sohag UniversityRecruitingUltrasonographic Assessement Of Diaphragm In Neuromuscular Diseases In Pediatric PatientsEgypt
-
Assiut UniversityNot yet recruitingTranexamic Acid Effect in Pediatric Polytraumatized Patients
-
Alcon ResearchCompletedPediatric Glaucoma | Elevated IOP in Pediatric Patients | Ocular Hypertension in Pediatric Patients
-
University Hospital Inselspital, BerneCompletedEvaluation of Success Rate | Airway Leak Pressure | Side Effects of LMA Supreme in Pediatric Patients Undergoing General AnesthesiaSwitzerland
Clinical Trials on Bupivacaine
-
Hospital Civil de GuadalajaraRecruitingEffect of Subarachnoid Hyperbaric Bupivacaine in Obese Pregnant Patients Undergoing Cesarean SectionAnesthesia | Obstetric Anesthesia ProblemsMexico
-
DurectNycomedCompletedPostoperative PainAustria, Germany, Latvia, Poland, Sweden
-
DurectNycomedCompletedPostoperative PainFrance, Germany, Hungary, Latvia, Sweden, United Kingdom
-
Hospital Civil de GuadalajaraCompletedAnesthesia, ObstetricalMexico
-
Indiana UniversityCompletedPain, Postoperative | Acute Pain | ThoracicUnited States
-
Seoul National University HospitalUnknownAnesthesia, Spinal [E03.155.086.331] | Operating Tables [E07.325.662]Korea, Republic of
-
Vanderbilt University Medical CenterCompletedAnesthesia | Breast Reconstruction | Transverse Abdominis Plane BlockUnited States
-
Indiana UniversityCompleted
-
Coordinación de Investigación en Salud, MexicoInstituto Mexicano del Seguro SocialCompletedObstetric PainMexico
-
Mayo ClinicCompletedPain, Postoperative | Brachial Plexus BlockUnited States