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

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04718259
• Other study ID #: Intrathecal midazolam
• Status: Completed
• Phase: Early Phase 1
• Start date: January 18, 2020
• Est. completion date: March 10, 2021

Study information

• Verified date: March 2021
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 10, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Analgesia
• Bupivacaine
• Children, Only
• Midazolam

Intervention

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

Locations

Country	Name	City	State
Saudi Arabia	Alemeis hospital ksa	Jazan

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Duration of analgesia	defined as the time elapsed since end of the surgical procedure till OPS reaches >11	90 days
Primary	Post operative resolution of motor block	will be assessed using Bromage score till complete recovery.	90 days
Primary	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
Primary	PO hospital stay	Duration of PO hospital stay	90 days
Secondary	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