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| Name | Class |
|---|---|
| Yichang Humanwell Pharmaceutical Co., Ltd., China | INDUSTRY |
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To observe the efficacy and safety of hydromorphone in the treatment of acute chest pain, and to explore the potential advantages of hydromorphone for analgesia in patients with acute chest pain, so as to provide more theoretical basis for individualized analgesia and rapid recovery in patients with acute chest pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | Hydromorphone 1mg was given intravenously and conventional treatment was performed at the same time. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydromorphone | Drug | Hydromorphone 1mg was given intravenously and conventional treatment was performed at the same time. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Relief at 30 Minutes After Administration | The difference between the NRS pain score before medication and the NRS pain score at 30 minutes after administration (i.e., NRS_before-NRS_at_30min). A larger value indicates a better analgesic effect. | 30 minutes post-medication |
| Measure | Description | Time Frame |
|---|---|---|
| NRS Pain Scores Over 60 Minutes | NRS pain scores will be measured at baseline (before administration) and at 5, 15, 30, 45, and 60 minutes post-administration. If additional analgesics or rescue medication are given, the NRS is re-measured 5 minutes afterward. | 0, 5, 15, 30, 45, and 60 minutes after administration (plus 5 minutes after any additional dose) |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hao Sun, MD, PhD | Contact | 13584017821 | 86 | haosun_6@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing Drum Tower Hospital | Recruiting | Nanjing | Jiangsu | 210008 | China |
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| ID | Term |
|---|---|
| D004091 | Hydromorphone |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| Analgesia Success Rate | The proportion of patients who do not require any additional analgesics within 60 minutes after the initial administration. | Up to 60 minutes post-administration |
| Adverse Events Within 60 Minutes | Incidence of adverse events (e.g., hypoventilation, bradycardia, nausea, vomiting, itching, or requirement of naloxone) within 60 minutes after administration. | 60 minutes post-administration |
| Total Dose of Rescue Medication | The cumulative dose of any rescue medication administered within 60 minutes after the initial analgesic administration. | 60 minutes post-administration |
| Blood Drug Concentration | Measurement of drug concentrations from blood samples collected at baseline, 2, 6, 12, and 24 hours after administration, to assess pharmacokinetics. | Baseline; 2, 6, 12, and 24 hours post-administration |
| Oxygen Saturation | Measurement of oxygen saturation recorded at baseline, 15, 30, 45, and 60 minutes post-administration. | Baseline; 15, 30, 45, and 60 minutes post-administration |
| Respiratory Rate | Measurement of respiratory rate recorded at baseline, 15, 30, 45, and 60 minutes post-administration. | Baseline; 15, 30, 45, and 60 minutes post-administration |
| Systolic Blood Pressure | Measurement of systolic blood pressure recorded at baseline, 15, 30, 45, and 60 minutes post-administration. | Baseline; 15, 30, 45, and 60 minutes post-administration |
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |