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NCT Number: NCT06949059

Intravenous Hydromorphone for the Treatment of Acute Pain

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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Key information

Conditions

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

Location status: Recruiting

Location contact

Hao Sun, MD, PhD

CONTACT

[email protected]

13584017821 ext. 86

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Known allergy to hydromorphone or morphine;
  • Systolic blood pressure <100 mmHg, oxygen saturation <95%, pulse less than 60 beats/min;
  • Use of acetaminophen or nonsteroidal anti-inflammatory drugs in the past 8 hours;
  • Chronic pain, defined as pain lasting for more than 12 weeks;
  • Delirium, alcohol withdrawal symptoms or other drug intoxication;
  • Pregnant or lactating women;
  • Patients with mental or neurological diseases, cognitive and consciousness disorders and inability to express correctly;
  • Participating in any other research at the same time;
  • 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.

Treatment and study plan

Hydromorphone

Drug

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

Primary outcomes

  1. Pain Relief at 30 Minutes After Administration

    Time frame: 30 minutes post-medication

    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.

Secondary outcomes

  1. NRS Pain Scores Over 60 Minutes

    Time frame: 0, 5, 15, 30, 45, and 60 minutes after administration (plus 5 minutes after any additional dose)

    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.

  2. Analgesia Success Rate

    Time frame: Up to 60 minutes post-administration

    The proportion of patients who do not require any additional analgesics within 60 minutes after the initial administration.

  3. Adverse Events Within 60 Minutes

    Time frame: 60 minutes post-administration

    Incidence of adverse events (e.g., hypoventilation, bradycardia, nausea, vomiting, itching, or requirement of naloxone) within 60 minutes after administration.

  4. Total Dose of Rescue Medication

    Time frame: 60 minutes post-administration

    The cumulative dose of any rescue medication administered within 60 minutes after the initial analgesic administration.

  5. Blood Drug Concentration

    Time frame: Baseline; 2, 6, 12, and 24 hours post-administration

    Measurement of drug concentrations from blood samples collected at baseline, 2, 6, 12, and 24 hours after administration, to assess pharmacokinetics.

  6. Oxygen Saturation

    Time frame: Baseline; 15, 30, 45, and 60 minutes post-administration

    Measurement of oxygen saturation recorded at baseline, 15, 30, 45, and 60 minutes post-administration.

  7. Respiratory Rate

    Time frame: Baseline; 15, 30, 45, and 60 minutes post-administration

    Measurement of respiratory rate recorded at baseline, 15, 30, 45, and 60 minutes post-administration.

  8. Systolic Blood Pressure

    Time frame: Baseline; 15, 30, 45, and 60 minutes post-administration

    Measurement of systolic blood pressure recorded at baseline, 15, 30, 45, and 60 minutes post-administration.

Study contacts

Contact information is provided by the study sponsor or research team.

Hao Sun, MD, PhD

CONTACT

[email protected]

13584017821 ext. 86

Sponsors and collaborators

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Other

Collaborators

  • Yichang Humanwell Pharmaceutical Co., Ltd., China

Registry information

Official study title

Intravenous Acetaminophen Versus Intravenous Hydromorphone for the Treatment of Acute Pain: A Single-Center, Prospective, Single-Arm Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 29, 2025
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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