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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04718259
Other study ID # Intrathecal midazolam
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
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
Health authority
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 .

Study Design


Related Conditions & MeSH terms


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
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