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Caudal Dexmetedomedine Versus Magnesium in Orthopedic Pediatric Surgeries

Caudal Dexmetedomedine Versus Magnesium in Orthopedic Pediatric Surgeries

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03460041
Enrollment
36
Registered
2018-03-09
Start date
2017-12-01
Completion date
2018-03-15
Last updated
2018-03-09

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

Conditions

Pain in Pediatric Patients

Brief summary

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.

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.

Interventions

DRUGMagnesium Sulfate

caudal magnesium sulphate added to bupivacaine for pain management

DRUGDexmetedomedine

Caudal dexmetedomedine added to bupivacaine for pain management

DRUGBupivacaine

Caudal bupivacaine for pain management

Sponsors

Cairo University
CollaboratorOTHER
Hagar hassanein refaee
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
1 Years to 7 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative pain12 hoursComparing duration of analgesia between caudal magnesium and caudal dexmetedomedine using flacc score

Countries

Egypt

Contacts

Primary ContactHagar Hassanein Refaee, Assistant lecturer
bibo_gogo12@yahoo.Com01063949855
Backup ContactMai Ahmed Aly, Lecturer

Outcome results

None listed

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