Pain in Pediatric Patients Clinical Trial
Official title:
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.
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.
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