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

March 17, 2021 updated by: MOHAMMED FAWZI ALI ABOSAMAK, Tanta University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Jazan, Saudi Arabia, 00966
        • Alemeis hospital ksa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Will include patients who will receive bupivacaine intrathecal injection without adjuvant.
Drug: intrathecal bupivacaine
The use of intrathecal bupivacaine will be compared to the use of intrathecal bupivacaine and midazolam.
Other Names:
  • intrathecal bupivacaine and midazolam
Experimental: Group B
Will include patients who will receive bupivacaine and midazolam.
Drug: midazolam
midazolam
Drug: intrathecal bupivacaine
The use of intrathecal bupivacaine will be compared to the use of intrathecal bupivacaine and midazolam.
Other Names:
  • intrathecal bupivacaine and midazolam

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2020

Primary Completion (Actual)

February 28, 2021

Study Completion (Actual)

March 10, 2021

Study Registration Dates

First Submitted

January 18, 2021

First Submitted That Met QC Criteria

January 20, 2021

First Posted (Actual)

January 22, 2021

Study Record Updates

Last Update Posted (Actual)

March 22, 2021

Last Update Submitted That Met QC Criteria

March 17, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Intrathecal midazolam

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

After analyzing the data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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