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Completed

NCT Number: NCT04718259

The Use of 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.

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Key information

Conditions

Analgesia Agnosia Bupivacaine Children, Only Midazolam Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Alemeis hospital ksa

Jizan, 00966, Saudi Arabia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

Intrathecal Bupivacaine

Drug

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

Other names: intrathecal bupivacaine and midazolam

midazolam

Drug

midazolam

Primary outcomes

  1. 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.

  2. Duration of analgesia

    Time frame: 90 days

    defined as the time elapsed since end of the surgical procedure till OPS reaches >11

  3. Post operative resolution of motor block

    Time frame: 90 days

    will be assessed using Bromage score till complete recovery.

  4. 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)

  5. PO hospital stay

    Time frame: 90 days

    Duration of PO hospital stay

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 22, 2021
Registry last updated
Mar 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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