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Comparison of the Efficacy of Intravenous Paracetamol and Ibuprofen in the Treatment of Fever Due to Upper Respiratory Tract Infection
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Fever | Drug: Paracetamol Drug: Ibuprofen | Phase 4 |
This is the randomized double blinded clinical trial to compare the efficacy of these two drugs in this clinical setting. A randomized clinical trial was conducted in the Emergency Department (ED) of Pamukkale University Medical Faculty Hospital Study personnel (emergency physicians and emergency service nurses) were trained before the study. When intravenous drugs (Paracetamol and İbuprofen) was being recommended, an eligibility checklist was completed by the attending physician. patients who presented to the emergency department with upper respiratory tract infection and had a temperature above 38.0 ° C were measured by a fever gauge included into the study First Group: 1000 mg of paracetamol ( parol 10mg/ml solution Mefar, Turkey) intravenous (IV) was given 100 patients
Second Group:
Ibuprofen 400 mg ( intrafen 400mg/4ml solution -Gen ilaç san., Turkey) intravenous (IV) was given 100 patients which determined to be applied as a group. Drug packs prepared in 150 ml serum physiology were numbered by an independent nurse, who not involved in the study Randomization was achieved by using computer software to generate random numbers. During the intervention, participants were monitored by an oxygen saturation (SpO2) monitor, an automatic sphygmomanometer (blood pressure), and a rhythm monitor (heart rate and rhythms). Patients in both groups received two types of medication in a similarmanner, thus ensuring double blind.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 200 participants |
| Allocation: | Randomized |
| Intervention Model: | Factorial Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | Comparison of the Efficacy of Intravenous Paracetamol and Ibuprofen in Patients With Upper Respiratory Tract Infections Presenting With Fever in the Emergency Department |
| Actual Study Start Date : | January 1, 2019 |
| Actual Primary Completion Date : | January 1, 2020 |
| Actual Study Completion Date : | January 1, 2020 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Paracetamol
Paracetamol 1000 mg of paracetamol (parol 10mg/ml solution Mefar,Turkey ) intravenous (IV) was given 100 patients
|
Drug: Paracetamol
1000 mg of paracetamol (parol 10mg/ml Mefar, Turkey) intravenous (IV) was given 100 patients Other Names:
|
|
Experimental: İbuprofen
İbuprofen 400mg of ibuprofen (intrafen 400mg/4ml solution Gen ilaç sanayi,Turkey ) intravenous (IV) was given 100 patients
|
Drug: Ibuprofen
400mg of ibuprofen(intrafen 400mg/4ml Gen ilaç sanayi, Turkey) intravenous (IV) was given 100 patients Other Names: Dorifen |
- Decreasing of fever [ Time Frame: Baseline and 120 minutes ]Comparison of the change of fever between the two groups. - (First group Paracetamol, Second Ibuprofen)
| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients who have fever for less than five days
- At least 1 upper respiratory tract infection (URTI) symptom according URTI questionare
Exclusion Criteria:
- Patients use anti-pyretic last 4 hours
- To be Pregnancy and breast-feeding Patients of childbearing age who are not using a birth control method
- Patients with an allergy trait (paracetamol and Ibuprofen) Illiterates
- Hemodynamically unstable patients
- Patients with renal transplantation
- Patients with glucose 6 phosphate dehydrogenase (G6PD) deficiency
- Patients with non-controlled hypertension
- Patients with a history of cerebrovascular disease
- Patients with severe liver, kidney,pulmonary and cardiac heart failure
- Patients use antibiotics last 7 days
- Patients with Wolff-Parkinson-White syndrome or accompanying arrhythmias associated with conductive stimulus delivery in the heart
- Patients with vision problems
| Turkey | |
| Pamukkale University | |
| Denizli, Turkey, 20070 | |
| Principal Investigator: | Atakan Yilmaz, MD | Pamukkale University | |
| Principal Investigator: | Gizem Oncel, MD | Pamukkale University |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 15, 2019 | ||||||
| First Posted Date ICMJE | April 17, 2019 | ||||||
| Last Update Posted Date | March 9, 2021 | ||||||
| Actual Study Start Date ICMJE | January 1, 2019 | ||||||
| Actual Primary Completion Date | January 1, 2020 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
Decreasing of fever [ Time Frame: Baseline and 120 minutes ] Comparison of the change of fever between the two groups. - (First group Paracetamol, Second Ibuprofen)
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||
| Change History | |||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Comparison of the Efficacy of Intravenous Paracetamol and Ibuprofen in the Treatment of Fever Due to Upper Respiratory Tract Infection | ||||||
| Official Title ICMJE | Comparison of the Efficacy of Intravenous Paracetamol and Ibuprofen in Patients With Upper Respiratory Tract Infections Presenting With Fever in the Emergency Department | ||||||
| Brief Summary | Currently, paracetamol, ibuprofen and nonsteroidal antiinflammatory drugs are widely used by emergency physicians in Turkey for the treatment of fever . The objective of the study is compare the efficacy of intravenous ibuprofen and paracetamol in the treatment of patients with upper respiratory tract infections presenting with fever in the emergency department | ||||||
| Detailed Description |
This is the randomized double blinded clinical trial to compare the efficacy of these two drugs in this clinical setting. A randomized clinical trial was conducted in the Emergency Department (ED) of Pamukkale University Medical Faculty Hospital Study personnel (emergency physicians and emergency service nurses) were trained before the study. When intravenous drugs (Paracetamol and İbuprofen) was being recommended, an eligibility checklist was completed by the attending physician. patients who presented to the emergency department with upper respiratory tract infection and had a temperature above 38.0 ° C were measured by a fever gauge included into the study First Group: 1000 mg of paracetamol ( parol 10mg/ml solution Mefar, Turkey) intravenous (IV) was given 100 patients Second Group: Ibuprofen 400 mg ( intrafen 400mg/4ml solution -Gen ilaç san., Turkey) intravenous (IV) was given 100 patients which determined to be applied as a group. Drug packs prepared in 150 ml serum physiology were numbered by an independent nurse, who not involved in the study Randomization was achieved by using computer software to generate random numbers. During the intervention, participants were monitored by an oxygen saturation (SpO2) monitor, an automatic sphygmomanometer (blood pressure), and a rhythm monitor (heart rate and rhythms). Patients in both groups received two types of medication in a similarmanner, thus ensuring double blind. |
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| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 4 | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Fever | ||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Completed | ||||||
| Actual Enrollment ICMJE |
200 | ||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||
| Actual Study Completion Date ICMJE | January 1, 2020 | ||||||
| Actual Primary Completion Date | January 1, 2020 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | Turkey | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT03918135 | ||||||
| Other Study ID Numbers ICMJE | 2019TIPF002 | ||||||
| Has Data Monitoring Committee | Yes | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Üzeyir Çimen, Pamukkale University | ||||||
| Study Sponsor ICMJE | Pamukkale University | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
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| PRS Account | Pamukkale University | ||||||
| Verification Date | March 2021 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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