PainPhase 2NCT00942539
Midazolam Sedation for Neonatal Lumbar Puncture
A Phase 2 study testing Midazolam in people with Pain and Anxiety, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Lumbar puncture is one of the most common painful procedures performed on neonates in the Emergency Department (ED). The investigators will study in a randomized controlled trial, the efficacy of intravenous administration of a single dose of Midazolam in reducing pain and anxiety in neonates undergoing lumbar… Read more about this study
- Who is it for?
- Ages 3 to 30 days
- What is being tested?
- Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2009to Jul 2011
- Phase
- Phase 2
- 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 30 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- American Society of Anesthesiologists (ASA) score I, II
- Post natal age ≤ 30 days
- Fasting of at least 2 hours before the procedure
Who cannot join
- American Society of Anesthesiologists (ASA) score III or greater
- Gestational age of 37 weeks or younger
- Congenital disease or defect
- Any medication provided by the caregiver prior ED admission
- Fasting of less than 2 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Midazolam Sedation for Neonatal Lumbar Puncture in the Emergency Department: A Randomized Controlled Trial
Lumbar puncture is one of the most common painful procedures performed on neonates in the Emergency Department (ED). The investigators will study in a randomized controlled trial, the efficacy of intravenous administration of a single dose of Midazolam in reducing pain and anxiety in neonates undergoing lumbar puncture in the ED, as well as the rate of adverse sedation reactions. The investigators hypothesize that compared with placebo, single dose Midazolam would significantly decrease pain and anxiety and will have low rate of adverse reactions.
- Being tested
- Midazolam
- Keywords
- Neonates
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
Intravenous infusion of 0.05 mg/kg of Midalolam
| Study group | Role | What they receive |
|---|---|---|
| Midazolam | Experimental | Administration of Midazolam prior Lumbar Puncture Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Simplified Neonatal Facial Coding System will be used for assessment of pain. Scoring will be composed from four specific facial actions (brow bulge, nasolabial furrow, eye squeeze, and open mouth) and the presence or absence of crying
Measured: 20 seconds prior lumbar puncture, during needle insertion, and 20 seconds post insertion
Secondary outcomes (3)
Physician's level of satisfaction from the procedural conditions
Measured: Five minutes post successful LP
LP Success rate
Measured: Five minutes post successful LP
Adverse sedation reactions
Measured: During procedure and during recovery phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, i_shavit, Rambam Health Care Campus
- Investigators
- Itai Shavit, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00942539
- Sponsor's protocol ID
- 2958CTIL
- Status last verified
- Jul 2010
- First submitted
- 18 Jul 2009
- Last updated
- 6 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Midazolam Sedation for Neonatal Lumbar Puncture in the Emergency Department: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00942539
- Acronym / sponsor ID
- 2958CTIL
- Keywords
- Neonates
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 21 Jul 2009 (estimated)
- 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.
Lumbar puncture is one of the most common painful procedures performed on neonates in the Emergency Department (ED). The investigators will study in a randomized controlled trial, the efficacy of intravenous administration of a single dose of Midazolam in reducing pain and anxiety in neonates undergoing lumbar puncture in the ED, as well as the rate of adverse sedation reactions. The investigators hypothesize that compared with placebo, single dose Midazolam would significantly decrease pain and anxiety and will have low rate of adverse reactions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Midazolam | Experimental | Drug: MidazolamAdministration of Midazolam prior Lumbar Puncture |
Who may qualify
- Ages
- 3 to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) score I, II
- Post natal age ≤ 30 days
- Fasting of at least 2 hours before the procedure
Key exclusion criteria (5 listed)
- American Society of Anesthesiologists (ASA) score III or greater
- Gestational age of 37 weeks or younger
- Congenital disease or defect
- Any medication provided by the caregiver prior ED admission
- Fasting of less than 2 hours
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 |
|---|---|---|
| MidazolamIntravenous infusion of 0.05 mg/kg of Midalolam | Drug | Midazolam |
Primary outcome
The Simplified Neonatal Facial Coding System will be used for assessment of pain. Scoring will be composed from four specific facial actions (brow bulge, nasolabial furrow, eye squeeze, and open mouth) and the presence or absence of crying
Time frame: 20 seconds prior lumbar puncture, during needle insertion, and 20 seconds post insertion
3 secondary outcomes
Physician's level of satisfaction from the procedural conditions
Time frame: Five minutes post successful LP
LP Success rate
Time frame: Five minutes post successful LP
Adverse sedation reactions
Time frame: During procedure and during recovery phase
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2014.
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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.
Itai Shavit, MD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Midazolam in people with Pain and Anxiety, run by Rambam Health Care Campus at 1 site in Israel.
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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 6 May 2014. 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 Israel. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early. Results are not available in the source record.
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?
The Simplified Neonatal Facial Coding System will be used for assessment of pain. Scoring will be composed from four specific facial actions (brow bulge, nasolabial furrow, eye squeeze, and open mouth) and the presence or absence of crying (time frame: 20 seconds prior lumbar puncture, during needle insertion, and 20 seconds post insertion). 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 6 May 2014.