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

Tanta University

Status and phase: Completed; Early Phase 1

Conditions: Bupivacaine; Midazolam; Children, Only; Analgesia

Treatments: Drug: intrathecal bupivacaine; Drug: midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT04718259

Intrathecal midazolam

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 3 to 12 years old

Volunteers: No Healthy Volunteers

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 .

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups

Group A

Experimental group

Description:

Will include patients who will receive bupivacaine intrathecal injection without adjuvant.

Treatment:

Drug: intrathecal bupivacaine

Group B

Experimental group

Description:

Will include patients who will receive bupivacaine and midazolam.

Treatment:

Drug: intrathecal bupivacaine

Drug: midazolam