Age-Based and Weight-Based Bupivacaine Dosing for Pediatric Spinal Anesthesia for Elective Infra-Umbilical Surgeries

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age1-6
SponsorCairo University

About this trial

Pediatric anesthesia presents distinctive challenges, particularly concerning appropriate dosage administration of local anesthetics for spinal anesthesia (SA). Spinal anesthesia in infants has been linked to a lower incidence of hypotension, hypoxia, bradycardia, and postoperative apnea in comparison to general anesthesia (GA); ensuring a high level of cardiovascular and respiratory stability.

Additionally, SA has been linked to lower operating room time, post-anesthesia care unit, hospital length of stay, corticosteroid administration, narcotic requirements, postoperative emesis, and cardiopulmonary complications in comparison to GA.

A reduction in systemic blood pressure frequently accompanies neuraxial blocks in adults, necessitating intervention. Nevertheless, spinal, caudal, or epidural blocks administered to children under six years old are not associated with any substantial alterations in blood pressure. In children aged 6 to 10, there is a linear decrease in blood pressure that will reach a plateau at approximately a 30% decrease in those beyond the age of 10. Conversely, younger children require no additional precautions.

Bupivacaine, has a narrow therapeutic index in children, and its dosing requires careful consideration to strike a balance between effective anesthesia and the risk of toxicity. The traditional method of dosing bupivacaine in pediatric spinal anesthesia is based on the child's body weight. This weight-based dosing considers the assumption that children's drug clearance correlates with their body mass. However, this approach might not account for the maturational changes in drug handling by pediatric patients or the variability in spinal column length and cerebrospinal fluid volumes, not always proportional to weight but may evolve with age.

Emerging evidence suggests that age-based dosing may be more effective. It hypothesizes that developmental pharmacokinetics, including changes in body composition, organ function, and drug-receptor differences, can influence bupivacaine metabolism and action more significantly than body mass alone. By accounting for the age-related anatomical and physiological changes, age-based dosing could result in more precise and effective anesthesia with a decreased risk of adverse outcomes.

To the authors knowledge, there is no study comparing age-based and weight-based bupivacaine dosing for pediatric spinal anesthesia in children undergoing elective infra-umbilical surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ASA I and II

Both genders

Elective infra-umbilical surgeries with anticipated duration ≤ 90 minutes.

Disqualifiers

Guardian refusal.

Children with major congenital heart disease, including septal defects.

Patients with neuromuscular disorders or high intracranial pressure.

Children with spinal deformities or morbid obesity (BMI above the 99th percentile).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Weight-based dosing

    Drug

    Hyperbaric bupivacaine 0.5% dosage will be calculated and administered intrathecally as 0.4 mg/kg or 0.08 ml/kg if body weight ≤ 15 kg and 0.3 mg/kg or 0.06 ml/kg if body weight \> 15 kg

  • Age-based dosing

    Drug

    Hyperbaric bupivacaine 0.5% will be administered at the dose of age divided by 5 (in ml). The age in months after the completion of a year was noted and considered as the next age if it is more than 6 months and the same age if it is ≤ 6 months.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Weight-based dosingActive comparator 1 intervention
Group B: Age-based dosing groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The peak sensory level

The sensory level of subarachnoid block, tested by firm skin pinch.

Time frame
5 mins after intrathecal bupivacaine injection

Secondary outcomes

1

Block level time

Time from injection of local anesthetic intrathecally to achieving full motor and adequate sensory block

Time frame
10 minutes from intrathecal injection of local anesthetic
2

Duration of the block

Duration from intrathecal injection of local anesthetic till return of motor power of the lower limbs

Time frame
120 minutes from intrathecal injection of local anesthetic
3

Postoperative pain score

Postoperative pain levels using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale

Time frame
3 hours from intrathecal injection of local anesthetic
4

Incidence of failed spinal blocks

Percentage of failed spinal blocks requiring conversion to general anesthesia

Time frame
2 hours from attempting subarachnoid block application

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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