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To evaluate the efficacy and safety of ibuprofen and sodium chloride injection in the treatment of fever

A multiple-center, randomized, parallel, double-controlled trial to evaluate the efficacy and safety of ibuprofen and sodium chloride injection in the treatment of fever

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IIR-17012445
Enrollment
Unknown
Registered
2017-08-26
Start date
2017-08-20
Completion date
Unknown
Last updated
2017-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

fever

Interventions

Treatment group: ibuprofen and sodium chloride injection

Sponsors

Shanghai 6th People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged from 18 to 65 years, male and female; 2. Axxillay temperature=38.5 degree C; 3. Had adequate intravenous access; 4. Had anticipated hospital stay=24hours; 5. Voluntary and signed ICF.

Exclusion criteria

Exclusion criteria: 1. Anticoagulants are being used, including parenteral medications, anticoagulants (such as heparin), coumarin anticoagulants (such as warfarin), antiplatelet agents such as aspirin, and lithium preparations, in combination with ACEI and diuretics; 2. Patients who had been treated with acetaminophen, such as aspirin, acetaminophen, and chlorpromazine, were treated 6 hours prior to randomization; 3. Patients with severe head trauma, hospitalization, or department of cerebral surgery, shock, or shock occurred within 30 days before randomization; 4. Patients undergoing systemic (oral / intravenous) corticosteroids should be treated during the trial; 5. The high risk of bleeding, including plateletcount of less than 50 x 10^9/l patients; bleeding, coagulation disorders (such as platelet dysfunction, hemophilia, idiopathic thrombocytopenic purpura,disseminated intravascular coagulation) patients, or clinically significant any active bleeding patients; 6. Over the past 6 months, there has been a history of myocardial infarction or stroke, or the presence of severe cardiovascular disease and risk factors, including unstable angina, heart failure, or life-threatening arrhythmias; 7. Hepatic or renal dysfunction (i.e., ALT or AST is greater than 1.5 times the normal limit; creatinine is greater than normal) or is being treated by dialysis; 8. There is a history of diabetes, after the hypoglycemic treatment, blood glucose control is not up to standard (random blood sugar, >11.1mmol/l), or accompanied by complications of diabetes (diabetic nephropathy, peripheral neuropathy); 9. Suffering from severe hypertension disease, drug control is still the systolic pressure is above 160mmhg, diastolic blood pressure or low blood pressure (> 90mmHg resting sitting blood pressure less than 90/50mmhg) patients; 10. The history of peptic ulcer or gastrointestinal bleeding within 6 weeks before randomization; 11. A mental illness, alcohol dependence, or history of drug abuse; 12. Lactating women, pregnant women, and during the period of medication or cessation of medication, 3 months after the birth of the child; 13. Allergies or previous multi drug allergy, or of Bloven, acetaminophen, COX-2 receptor antagonists and other non steroidal anti-inflammatory drugs, and arginine and other ingredients have allergic patients, or after taking aspirin had asthma, urticaria or allergic patients; 14. 3 months before the trial, they participated in other clinical studies; 15. Patients who were not eligible for the study were thought to be involved in the study.

Design outcomes

Primary

MeasureTime frame
For the first time after 4 hours, the test group and control group, two groups were less than or equal to 38 DEG C temperature (axillary temperature) the proportion of patients;

Secondary

MeasureTime frame
The rate of treatment failure within 24 hours of medication;;4 hours after the first dose of ibuprofen, again to the Sodium Chloride Injection 100ml, 50ml, 25ml, maintain temperature is not higher than 38 DEG (armpit) proportion of patients;;The cooling time: the first treatment to the first temperature below 38 DEG C (armpit) time;The change in area (AUC) of the body temperature time curve within 4 hours of the first dose;Within 4-24 hours, the dose (100ml, 50ml, 25ml) curves of different doses and body temperature (AUC) were measured;After 24 hours, the number of patients with more than 1 DEG C temperature decreased and the proportion of /h.;

Countries

China

Contacts

Public ContactShen Ce

Shanghai Sixth People's Hospital

lysamshen@qq.com+86 021-24058361

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026