Intravenous Hydromorphone for the Treatment of Acute Pain

NCT ID: NCT06949059

Last Updated: 2025-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Chest Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment Group

Hydromorphone 1mg was given intravenously and conventional treatment was performed at the same time.

Group Type EXPERIMENTAL

Hydromorphone

Intervention Type DRUG

Hydromorphone 1mg was given intravenously and conventional treatment was performed at the same time.

Interventions

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Hydromorphone

Hydromorphone 1mg was given intravenously and conventional treatment was performed at the same time.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age 18-64 years old;
2. Gender is not limited;
3. Patients with acute chest pain, with the time from pain onset to visit the doctor ≤ 24 days;
4. Severe pain that requires the use of opioids to control as determined by emergency physicians;
5. Obtain informed consent from the patient or family members.

Exclusion Criteria

1. Known allergy to hydromorphone or morphine;
2. Systolic blood pressure \<100 mmHg, oxygen saturation \<95%, pulse less than 60 beats/min;
3. Use of acetaminophen or nonsteroidal anti-inflammatory drugs in the past 8 hours;
4. Chronic pain, defined as pain lasting for more than 12 weeks;
5. Delirium, alcohol withdrawal symptoms or other drug intoxication;
6. Pregnant or lactating women;
7. Patients with mental or neurological diseases, cognitive and consciousness disorders and inability to express correctly;
8. Participating in any other research at the same time;
9. Factors that increase the risk of participating in the study (life-threatening chest pain patients who require rapid diagnosis or treatment intervention, such as resuscitation status, excluding chest pain caused by myocardial infarction), who are judged by the researchers to be unsuitable for inclusion in the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yichang Humanwell Pharmaceutical Co., Ltd., China

INDUSTRY

Sponsor Role collaborator

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role lead

Responsible Party

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Hao Sun

Principal Investigator, Clinical Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hao Sun, MD, PhD

Role: CONTACT

13584017821 ext. 86

Facility Contacts

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Hao Sun, MD, PhD

Role: primary

13584017821 ext. 86

Other Identifiers

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2024-320-03

Identifier Type: -

Identifier Source: org_study_id

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