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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-18

Study Completion Date

2021-03-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Unilateral Transversus Abdominis Plane Block in Pediatrics

NCT04539314

Unilateral TAP Block in Pediatric Patients Undergoing Lower Abdominal Surgery

COMPLETED NA

Caudal Block With Bupivacaine and Dexmedetomidine Versus TAP Block With Bupivacaine Alone for Postoperative Analgesia in Pediatric Undergoing Infraumbical Surgeries

NCT06183073

Postoperative Pain

RECRUITING PHASE2

Parasternal Nerve Block Using Bupivacaine for Postoperative Analgesia in Children Undergoing Cardiac Surgery

NCT02512861

Pain

COMPLETED PHASE4

Intrathecal Injection of Hyperbaric Bupivacaine Versus a Mixture of Hyperbaric and Isobaric Bupivacaine in Patients Undergoing Lower Abdominal Surgery

NCT06050044

Spinal Anesthesia Hyperbaric Bupivacaine Isobaric Bupivacaine +1 more

COMPLETED NA

Postoperative Pain Control in Children Undergoing Laparoscopic Appendectomy: Peripheral Nerve Block Versus Local Anesthetic

NCT01662401

Postoperative Pain

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Analgesia Children, Only Bupivacaine Midazolam

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group A

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

Group Type EXPERIMENTAL

intrathecal bupivacaine

Intervention Type DRUG

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

Group B

Will include patients who will receive bupivacaine and midazolam.

Group Type EXPERIMENTAL

intrathecal bupivacaine

Intervention Type DRUG

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

midazolam

Intervention Type DRUG

midazolam

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

intrathecal bupivacaine

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

Intervention Type DRUG

midazolam

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

intrathecal bupivacaine and midazolam

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 .

Minimum Eligible Age

3 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No