About this trial
This prospective randomized double-blinded controlled trial will include 60 pediatric patients aged 1 - 6 years old, both sexes, with American society of anesthesiologists (I and II) and undergoing elective infra-umbilical surgeries with anticipated duration ≤ 90 minutes. Patients will be randomly divided into two equal groups: Weight-based dosing (Group A) and age-based dosing group (Group B). Both groups will receive hyperbaric bupivacaine 0.5%. The aim of the study is to evaluate the effectiveness of using age based dosing of Bupivacaine compared with standard method of weight based dosing in pediatric spinal anesthesia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children aged 1-6 years
Both genders.
American Society of Anesthesiologists (ASA) physical status I or II.
Elective infra-umbilical surgeries with anticipated duration ≤ 90 minutes.
Disqualifiers
Guardian refusal.
Children with significant congenital heart disease (e.g., septal defects requiring surgical intervention)
Children with neuromuscular disorders or high intracranial pressure.
Children with spinal deformities or morbid obesity (body mass index (BMI) above the 99th percentile).
Trial design
Parallel
Treatments tested in this trial
Spinal Anesthesia with Bupivacaine
Procedure/SurgeryGroup A (n=30) will receive spinal anesthesia according to the weight-based dosing calculation of bupivacaine.
Spinal Anesthesia with Bupivacaine
Procedure/SurgeryGroup B (n=30) will receive spinal anesthesia according to the age-based dosing calculation of bupivacaine.
Treatment groups
Trial outcomes
Primary outcomes
The peak sensory level
The peak sensory level will be assessed 5 minutes after intrathecal bupivacaine injection, and evaluated by a firm skin pinch.
Secondary outcomes
Time of completion of spinal block
Time in seconds to complete block administration starting at the time of application of Betadine on the site of lumbar puncture to the time at which the patient is placed on their back after administration of spinal anesthesia
Duration of spinal block
Duration of block: the time in minutes from achieving peak sensory and motor level to the onset of pain or the movement of the legs.
Postoperative pain score
Postoperative pain score will be recorded using the Face, Legs, Activity, Cry, and Consolability (FLACC) Scale at 2, 4, and 6 hours from block administration. The scale consists of five categories: Face, Legs, Activity, Cry, and Consolability, each of which is scored from 0 to 2. A score of 0 represents no pain or distress, while a score of 2 indicates significant discomfort or distress.
The need for rescue analgesia in PACU
The need for rescue analgesia in PACU: IV Pethidine 1 mg/kg will be administered once for a pain score of 6 or higher using FLACC scale
Other outcomes
Systolic blood pressure (SBP)
SBP will be recorded at T0 (baseline values before administration of block), then upon administration of spinal anesthesia, then every 3 minutes for 15 minutes, then every 5 minutes for the duration of the surgery.
Diastolic blood pressure (DBP)
DBP will be recorded at T0 (baseline values before administration of block), then upon administration of spinal anesthesia, then every 3 minutes for 15 minutes, then every 5 minutes for the duration of the surgery.
Mean blood pressure (MBP)
MBP will be recorded at T0 (baseline values before administration of block), then upon administration of spinal anesthesia, then every 3 minutes for 15 minutes, then every 5 minutes for the duration of the surgery.
The dose bupivacaine administered.
The dose in millilitres of bupivacaine administered in each group will be recorded.
Sponsors and contacts
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