Safety IssuesPhase 4NCT04608669
Paracetamol Hypothermia Children
A Phase 4 study testing Paracetamol in people with Safety Issues, run by Saint George Hospital at 1 site in Lebanon.
Trial summary
Transient Acetaminophen Induced Hypothermia in Pediatrics Population Undergoing General Anesthesia Read more about this study
- Who is it for?
- Ages 0 days to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety Issues
- What is being tested?
- Paracetamol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Jul 2019to 30 Sep 2020
- Phase
- Phase 4
- 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 0 days to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- -
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transient Acetaminophen Induced Hypothermia in Pediatrics Population Undergoing General Anesthesia
Transient Acetaminophen Induced Hypothermia in Pediatrics Population Undergoing General Anesthesia
- Conditions
- Safety Issues
- Being tested
- Paracetamol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParacetamolDrug
Give paracetamol or placebo and compare temperature
| Study group | Role | What they receive |
|---|---|---|
| Temperature comparison | Other | Not described Receives: Drug: Paracetamol |
| No change | Active comparator | Not described Receives: Drug: Paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temperature variation
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start1 Jul 2019
- Primary completion30 Sep 2019
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety IssuesStudies 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint George Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hazem Kafrouni, Saint George Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04608669
- Sponsor's protocol ID
- SaintgeorgeHh
- Status last verified
- Mar 2021
- First submitted
- 24 Oct 2020
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transient Acetaminophen Induced Hypothermia in Pediatrics Population Undergoing General Anesthesia
- ClinicalTrials.gov ID
- NCT04608669
- Acronym / sponsor ID
- SaintgeorgeHh
- Conditions
- Safety Issues
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Saint George HospitalUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 29 Oct 2020 (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.
Transient Acetaminophen Induced Hypothermia in Pediatrics Population Undergoing General Anesthesia
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Temperature comparison | Other | Drug: Paracetamol |
| No change | Active comparator | Drug: Paracetamol |
Who may qualify
- Ages
- 0 days to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| ParacetamolGive paracetamol or placebo and compare temperature | Drug | No change, Temperature comparison |
Primary outcome
Temperature variation
Time frame: 3 months
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 18 Mar 2021.
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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 Phase 4 study testing Paracetamol in people with Safety Issues, run by Saint George Hospital at 1 site in Lebanon.
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 18 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 Lebanon. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Temperature variation (time frame: 3 months). 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 18 Mar 2021.