NCT04718259

The Use of Midazolam as Adjuvant to Bupivacaine Intrathecal Anesthesia for Children Undergoing Lower Abdominal Surgeries.

Evaluation of the Intraoperative and PO Analgesic Outcome of Using Midazolam as Adjuvant to Bupivacaine Intrathecal Anesthesia for Children Undergoing Lower Abdominal Surgeries.

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 3 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

The study will be carried on children undergoing lower abdominal surgeries. Patients will be randomly categorized into two study groups. Group A will include patients who will receive bupivacaine intrathecal injection without adjuvant. Group B will include patients who will receive bupivacaine and preservative-free midazolam.

Conditions

• Analgesia
• Children, Only
• Bupivacaine
• Midazolam

Interventions

Type	Name	Description
DRUG	intrathecal bupivacaine	The use of intrathecal bupivacaine will be compared to the use of intrathecal bupivacaine and midazolam.
DRUG	midazolam	midazolam

Timeline

• Start date: 2020-01-18
• Primary completion: 2021-02-28
• Completion: 2021-03-10
• First posted: 2021-01-22
• Last updated: 2021-03-22

Locations

1 site across 1 country: Saudi Arabia

Regulatory

• FDA-regulated drug study