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

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04718259

Enrollment

120

Registered

2021-01-22

Start date

2020-01-18

Completion date

2021-03-10

Last updated

2021-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia, Children, Only, Bupivacaine, Midazolam

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.

Interventions

DRUGintrathecal bupivacaine

The use of intrathecal bupivacaine will be compared to the use of intrathecal bupivacaine and midazolam.

DRUGmidazolam

midazolam

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

3 Years to 12 Years

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 .

Design outcomes

Primary

Measure	Time frame	Description
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.
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

Secondary

Measure	Time frame	Description
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.

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026