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

Study Overview
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Brief Summary
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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.

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

Conditions
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Analgesia, Children, Only, Bupivacaine, Midazolam

Intervention / Treatment
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* Drug: intrathecal bupivacaine
* Drug: midazolam


Participation Criteria
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Eligibility Criteria
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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 .

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Will include patients who will receive bupivacaine intrathecal injection without adjuvant. | Drug: intrathecal bupivacaine<br>* The use of intrathecal bupivacaine will be compared to the use of intrathecal bupivacaine and midazolam.<br>* Other names: intrathecal bupivacaine and midazolam;|
| Experimental: Group B<br>Will include patients who will receive bupivacaine and midazolam. | Drug: intrathecal bupivacaine<br>* The use of intrathecal bupivacaine will be compared to the use of intrathecal bupivacaine and midazolam.<br>* Other names: intrathecal bupivacaine and midazolam;Drug: midazolam<br>* midazolam<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of postoperative analgesia | 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. | 90 days | 
| Duration of analgesia | defined as the time elapsed since end of the surgical procedure till OPS reaches >11 | 90 days | 
| Post operative resolution of motor block | will be assessed using Bromage score till complete recovery. | 90 days | 
| The level of Post operative sedation | will be assessed at 30 & 120 minutes after admission to the recovery room using the modified WilsonSedation Score (WSS) | 90 days | 
| PO hospital stay | Duration of PO hospital stay | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of procedural success | 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. | 90 days |