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

NCT04718259 | Completed Early Phase 1 FDA Drug

• 1 other identifier: Intrathecal midazolam
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Analgesia; Children, Only; Bupivacaine; Midazolam

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (1)

• The rate of procedural success

  90 days

Study Arms (2)

Group A

EXPERIMENTAL

Will include patients who will receive bupivacaine intrathecal injection without adjuvant.

Drug: intrathecal bupivacaine

Group B

EXPERIMENTAL

Will include patients who will receive bupivacaine and midazolam.

Drug: intrathecal bupivacaine; Drug: midazolam

Interventions

intrathecal bupivacaine DRUG

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

Also known as: intrathecal bupivacaine and midazolam

Group A; Group B

midazolam DRUG

midazolam

Group B

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Alemeis hospital ksa

Jizan, 00966, Saudi Arabia

Location

MeSH Terms

Conditions

Agnosia

Interventions

Midazolam

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: consultant anesthesia

Study Record Dates

• First Submitted: January 18, 2021
• First Posted: January 22, 2021
• Study Start: January 18, 2020
• Primary Completion: February 28, 2021
• Study Completion: March 10, 2021
• Last Updated: March 22, 2021

Record last verified: 2021-03

Locations

SA (1)