AnalgesiaEarly Phase 1NCT04718259
The Use of Midazolam as Adjuvant to Bupivacaine Intrathecal Anesthesia for Children Undergoing Lower Abdominal Surgeries.
A Early Phase 1 study testing intrathecal bupivacaine and midazolam in people with Analgesia and Children, Only, run by Tanta University at 1 site in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Analgesia, Children, Only, Bupivacaine
- What is being tested?
- intrathecal bupivacaine and midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 18 Jan 2020to 10 Mar 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Analgesia, Children, Only, Bupivacaine, Midazolam
- Being tested
- intrathecal bupivacaine, midazolam
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intrathecal bupivacaineDrug
Also called intrathecal bupivacaine and midazolam
The use of intrathecal bupivacaine will be compared to the use of intrathecal bupivacaine and midazolam.
midazolamDrug
midazolam
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Will include patients who will receive bupivacaine intrathecal injection without adjuvant. Receives: Drug: intrathecal bupivacaine |
| Group B | Experimental | Will include patients who will receive bupivacaine and midazolam. Receives: Drug: intrathecal bupivacaine; Drug: midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Duration of analgesia
defined as the time elapsed since end of the surgical procedure till OPS reaches >11
Measured: 90 days
Post operative resolution of motor block
will be assessed using Bromage score till complete recovery.
Measured: 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)
Measured: 90 days
PO hospital stay
Duration of PO hospital stay
Measured: 90 days
Secondary outcomes (1)
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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start18 Jan 2020
- Primary completion28 Feb 2021
- Study completion10 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MOHAMMED FAWZI ALI ABOSAMAK, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04718259
- Sponsor's protocol ID
- Intrathecal midazolam
- Status last verified
- Mar 2021
- First submitted
- 18 Jan 2021
- Last updated
- 22 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: After analyzing the data.
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Intraoperative and PO Analgesic Outcome of Using Midazolam as Adjuvant to Bupivacaine Intrathecal Anesthesia for Children Undergoing Lower Abdominal Surgeries.
- ClinicalTrials.gov ID
- NCT04718259
- Acronym / sponsor ID
- Intrathecal midazolam
- Conditions
- Analgesia, Children, Only, Bupivacaine, Midazolam
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 18 Jan 2020 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 10 Mar 2021 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: intrathecal bupivacaineWill include patients who will receive bupivacaine intrathecal injection without adjuvant. |
| Group B | Experimental | Drug: intrathecal bupivacaine, Drug: midazolamWill include patients who will receive bupivacaine and midazolam. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intrathecal bupivacaineAlso: intrathecal bupivacaine and midazolamThe use of intrathecal bupivacaine will be compared to the use of intrathecal bupivacaine and midazolam. | Drug | Group A, Group B |
| midazolammidazolam | Drug | Group B |
Primary outcome
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.
Duration of analgesia
Time frame: 90 days
defined as the time elapsed since end of the surgical procedure till OPS reaches >11
Post operative resolution of motor block
Time frame: 90 days
will be assessed using Bromage score till complete recovery.
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)
PO hospital stay
Time frame: 90 days
Duration of PO hospital stay
1 secondary outcome
The rate of procedural success
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
- Individual participant dataSharing planned: Undecided. After analyzing the data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing intrathecal bupivacaine and midazolam in people with Analgesia and Children, Only, run by Tanta University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of postoperative analgesia (time frame: 90 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2021.