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

Early Phase 1

Completed

• Conditions: Bupivacaine; Midazolam; Analgesia; Children, Only
• Interventions: Drug: intrathecal bupivacaine; Drug: midazolam

• Registration Number: NCT04718259
• Lead Sponsor: Tanta University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-18
• Study First Submitted: 2021-01-18
• Study First Submitted QC: 2021-01-20
• Study First Posted: 2021-01-22
• Primary Completion: 2021-02-28
• Status Verified: 2021-03
• Study Completion: 2021-03-10
• Last Update Submitted: 2021-03-17
• Last Update Posted: 2021-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• All children aged 3-12 years, assigned for lower abdominal and pelvic surgeries and will be ASA grade I after obtaining written fully informed parental consent.

Exclusion Criteria

• Patients with congenital anomalies especially of the spine, infections in the skin of the back, had coagulopathy, or allergy to the study drugs and those whose parents refused to give the consent .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	intrathecal bupivacaine	Will include patients who will receive bupivacaine and midazolam.
Group A	intrathecal bupivacaine	Will include patients who will receive bupivacaine intrathecal injection without adjuvant.
Group B	midazolam	Will include patients who will receive bupivacaine and midazolam.

Primary Outcome Measures

Name	Time	Method
The level of Post operative sedation	90 days	will be assessed at 30 \& 120 minutes after admission to the recovery room using the modified WilsonSedation Score (WSS)
PO hospital stay	90 days	Duration of PO hospital stay
Duration of postoperative analgesia	90 days	Efficacy of PO analgesia will be determined, by an assistant who will be blinded about the using the observational pain-discomfort scale (OPS), which assesses behavioral parameters that can be evaluated objectively.
Duration of analgesia	90 days	defined as the time elapsed since end of the surgical procedure till OPS reaches \>11
Post operative resolution of motor block	90 days	will be assessed using Bromage score till complete recovery.

Secondary Outcome Measures

Name	Time	Method
The rate of procedural success	90 days	Defined as peak sensory level at least T10, Bromage score at 3 at 10-min after spina block and no response to surgical stimuli once surgery will be allowed to start.

Trial Locations

Locations (1)

Alemeis hospital ksa; 🇸🇦 Jazan, Saudi Arabia