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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Will include patients who will receive bupivacaine intrathecal injection without adjuvant. |
|
| Group B | Experimental | Will include patients who will receive bupivacaine and midazolam. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intrathecal bupivacaine | Drug | The use of intrathecal bupivacaine will be compared to the use of intrathecal bupivacaine and midazolam. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alemeis hospital ksa | Jizan | 00966 | Saudi Arabia |
After analyzing the data.
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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|
| midazolam | Drug | midazolam |
|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 | Heterocyclic Compounds |