Patients With Moderate to Severe Pain Requiring Analgesic MedicationsNCT07031453
Observation and Study on the Application of Different Analgesic Regimens in Critically Ill Patients Without Mechanical Ventilation
An observational study of Patients With Moderate to Severe Pain Requiring Analgesic Medications, run by Peking University People's Hospital.
Trial summary
Pain management is a common treatment measure in the Intensive Care Unit (ICU). Due to their underlying diseases and invasive treatments, patients often experience discomfort and pain, leading to agitation, unplanned extubation, patient-ventilator asynchrony, and even neuroendocrine-immune dysregulation, sympathetic… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Patients With Moderate to Severe Pain Requiring Analgesic Medications
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jun 2025to Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The cohort will be selected from a tertiary hospital
Who may be able to join
- Age ≥18 and ≤75 years; Non-mechanically ventilated patients (including post-extubation patients) with an anticipated ICU stay >24 hours; Patients with moderate to severe pain requiring analgesic therapy; Informed consent obtained from the patient or legal guardian.
Who cannot join
- Age <18 or >75 years; Pregnancy or lactation; Patients scheduled for general anesthesia surgery within 48 hours; Severe pre-existing parenchymal liver disease with clinically significant portal hypertension, Child-Pugh Class C cirrhosis, or acute liver failure; Bronchial asthma, COPD, or myasthenia gravis patients; Severe traumatic brain injury, brain tumors, intracranial hypertension, or other conditions predisposing to respiratory depression; History of alcohol or drug abuse; Any condition impairing cognitive assessment (e.g., language/sensory impairment or psychiatric disorders, such as aphasia or organic mental dysfunction); Inability to obtain informed consent or authorization; Participation in other investigational clinical trials within 6 months prior to screening; Known allergy to the study medication.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Observational Study on the Application of Different Analgesic Regimens in Non-Mechanically Ventilated Critically Ill Patients
Pain management is a common treatment measure in the Intensive Care Unit (ICU). Due to their underlying diseases and invasive treatments, patients often experience discomfort and pain, leading to agitation, unplanned extubation, patient-ventilator asynchrony, and even neuroendocrine-immune dysregulation, sympathetic overexcitation, and impaired organ function. Analgesic therapy can reduce patient stress and increase comfort, making it an essential treatment for critically ill patients. However, it may also cause adverse effects such as respiratory depression and decreased gastrointestinal motility. There is currently no consensus on how to precisely implement analgesic therapy in non-mechanically ventilated critically ill patients to reduce adverse effects like respiratory depression.This prospective observational study will enroll non-mechanically ventilated critically ill patients receiving analgesic therapy. It will observe different analgesic strategies, including factors such as pain assessment status, drug types, duration of analgesia, and cumulative drug doses, to understand their effects and adverse reactions in non-mechanically ventilated patients. The study aims to explore optimized analgesic treatment regimens and provide evidence-based support for implementing precise analgesic therapy in clinical practice.
Read the detailed description
Pain management is a critical component of treatment for critically ill patients, particularly in non-mechanically ventilated patient populations. Appropriate analgesic therapy not only impacts patient comfort but also directly influences disease outcomes and medical safety. Non-ventilated patients often endure moderate-to-severe pain due to conditions such as postoperative trauma, advanced cancer, and acute pancreatitis. Pain-induced stress responses can lead to tachycardia, hypertension, increased oxygen consumption, and immunosuppression. Studies indicate that inadequately controlled acute pain increases myocardial infarction risk by 2.3-fold and deep vein thrombosis incidence by 1.8-fold, with strong correlations to chronic pain persistence.
However, implementing analgesic therapy faces dual challenges:
- Pain assessment tends to be delayed in patients with impaired consciousness or communication difficulties, resulting in undertreatment;
- Analgesic drugs carry complex side-effect profiles, with opioid-associated respiratory depression occurring in 9%-12% of cases, and NSAIDs increasing gastrointestinal bleeding risk by 4.7-fold. These complications may have catastrophic consequences in non-ventilated patients. Taking respiratory depression as an example: non-ventilated patients lack artificial airway protection. Even mild reductions in respiratory rate can cause hypercapnia, potentially necessitating emergency intubation. Mortality rates among these emergently intubated patients are 3.2 times higher than those with planned intubation[3]. This therapeutic dilemma makes precise analgesic regimen selection a core clinical challenge.Notably, the novel analgesic hydromorphone-a semi-synthetic morphine derivative-exhibits 8-10 times greater analgesic potency than morphine with a non-ceiling effect. It offers rapid onset, non-toxic metabolites, and diverse administration routes, demonstrating superior clinical applicability especially in patients with hepatic/renal impairment. Preliminary studies suggest hydromorphone significantly reduces respiratory depression and gastrointestinal adverse events compared to traditional opioids. Nevertheless, clinical data in non-ventilated patients remain limited, warranting systematic evaluation.
- Keywords
- Patients with moderate to severe pain requiring analgesic medications., Sedation, respiratory depression, gastrointestinal paralysis
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Respiratory depression and gastrointestinal paralysis occurred | Not described | |
| No respiratory depression or gastrointestinal paralysis occurred | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of time points achieving the target analgesic score range among all time points.
Measured: The observation period starts from patient enrollment and lasts for 7 days or until transfer out of the intensive care unit (ICU).
Secondary outcomes (4)
Total dosage of analgesics
Measured: The observation period starts from patient enrollment and lasts for 7 days or until transfer out of the intensive care unit (ICU).
incidence of adverse events (including but not limited to cardiovascular/respiratory depression, delayed gastrointestinal motility recovery, nausea/vomiting, and pruritus)
Measured: The observation period starts from patient enrollment and lasts for 7 days or until transfer out of the intensive care unit (ICU).
in-hospital/ICU mortality
Measured: The observation period starts from patient enrollment and lasts for 7 days or until transfer out of the intensive care unit (ICU).
length of hospital stay, and ICU length of stay
Measured: The observation period starts from patient enrollment and lasts for 7 days or until transfer out of the intensive care unit (ICU).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study startJun 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Moderate to Severe Pain Requiring Analgesic MedicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Shu, Peking University People's Hospital
- Investigators
- Shu Li, doctor, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07031453
- Sponsor's protocol ID
- 2025-Z-40
- Status last verified
- Jun 2025
- First submitted
- 12 Jun 2025
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD，all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on the Application of Different Analgesic Regimens in Non-Mechanically Ventilated Critically Ill Patients
- ClinicalTrials.gov ID
- NCT07031453
- Acronym / sponsor ID
- 2025-Z-40
- Keywords
- Patients with moderate to severe pain requiring analgesic medications., Sedation, respiratory depression, gastrointestinal paralysis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 22 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pain management is a common treatment measure in the Intensive Care Unit (ICU). Due to their underlying diseases and invasive treatments, patients often experience discomfort and pain, leading to agitation, unplanned extubation, patient-ventilator asynchrony, and even neuroendocrine-immune dysregulation, sympathetic overexcitation, and impaired organ function. Analgesic therapy can reduce patient stress and increase comfort, making it an essential treatment for critically ill patients. However, it may also cause adverse effects such as respiratory depression and decreased gastrointestinal motility. There is currently no consensus on how to precisely implement analgesic therapy in non-mechanically ventilated critically ill patients to reduce adverse effects like respiratory depression.This prospective observational study will enroll non-mechanically ventilated critically ill patients receiving analgesic therapy. It will observe different analgesic strategies, including factors such as pain assessment status, drug types, duration of analgesia, and cumulative drug doses, to understand their effects and adverse reactions in non-mechanically ventilated patients. The study aims to explore optimized analgesic treatment regimens and provide evidence-based support for implementing precise analgesic therapy in clinical practice.
Detailed description
Pain management is a critical component of treatment for critically ill patients, particularly in non-mechanically ventilated patient populations. Appropriate analgesic therapy not only impacts patient comfort but also directly influences disease outcomes and medical safety. Non-ventilated patients often endure moderate-to-severe pain due to conditions such as postoperative trauma, advanced cancer, and acute pancreatitis. Pain-induced stress responses can lead to tachycardia, hypertension, increased oxygen consumption, and immunosuppression. Studies indicate that inadequately controlled acute pain increases myocardial infarction risk by 2.3-fold and deep vein thrombosis incidence by 1.8-fold, with strong correlations to chronic pain persistence.
However, implementing analgesic therapy faces dual challenges:
- Pain assessment tends to be delayed in patients with impaired consciousness or communication difficulties, resulting in undertreatment;
- Analgesic drugs carry complex side-effect profiles, with opioid-associated respiratory depression occurring in 9%-12% of cases, and NSAIDs increasing gastrointestinal bleeding risk by 4.7-fold. These complications may have catastrophic consequences in non-ventilated patients. Taking respiratory depression as an example: non-ventilated patients lack artificial airway protection. Even mild reductions in respiratory rate can cause hypercapnia, potentially necessitating emergency intubation. Mortality rates among these emergently intubated patients are 3.2 times higher than those with planned intubation[3]. This therapeutic dilemma makes precise analgesic regimen selection a core clinical challenge.Notably, the novel analgesic hydromorphone-a semi-synthetic morphine derivative-exhibits 8-10 times greater analgesic potency than morphine with a non-ceiling effect. It offers rapid onset, non-toxic metabolites, and diverse administration routes, demonstrating superior clinical applicability especially in patients with hepatic/renal impairment. Preliminary studies suggest hydromorphone significantly reduces respiratory depression and gastrointestinal adverse events compared to traditional opioids. Nevertheless, clinical data in non-ventilated patients remain limited, warranting systematic evaluation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Respiratory depression and gastrointestinal paralysis occurred | – | – |
| No respiratory depression or gastrointestinal paralysis occurred | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The cohort will be selected from a tertiary hospital
Key inclusion criteria (1 listed)
- Age ≥18 and ≤75 years; Non-mechanically ventilated patients (including post-extubation patients) with an anticipated ICU stay >24 hours; Patients with moderate to severe pain requiring analgesic therapy; Informed consent obtained from the patient or legal guardian.
Key exclusion criteria (1 listed)
- Age <18 or >75 years; Pregnancy or lactation; Patients scheduled for general anesthesia surgery within 48 hours; Severe pre-existing parenchymal liver disease with clinically significant portal hypertension, Child-Pugh Class C cirrhosis, or acute liver failure; Bronchial asthma, COPD, or myasthenia gravis patients; Severe traumatic brain injury, brain tumors, intracranial hypertension, or other conditions predisposing to respiratory depression; History of alcohol or drug abuse; Any condition impairing cognitive assessment (e.g., language/sensory impairment or psychiatric disorders, such as aphasia or organic mental dysfunction); Inability to obtain informed consent or authorization; Participation in other investigational clinical trials within 6 months prior to screening; Known allergy to the study medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The proportion of time points achieving the target analgesic score range among all time points.
Time frame: The observation period starts from patient enrollment and lasts for 7 days or until transfer out of the intensive care unit (ICU).
4 secondary outcomes
Total dosage of analgesics
Time frame: The observation period starts from patient enrollment and lasts for 7 days or until transfer out of the intensive care unit (ICU).
incidence of adverse events (including but not limited to cardiovascular/respiratory depression, delayed gastrointestinal motility recovery, nausea/vomiting, and pruritus)
Time frame: The observation period starts from patient enrollment and lasts for 7 days or until transfer out of the intensive care unit (ICU).
in-hospital/ICU mortality
Time frame: The observation period starts from patient enrollment and lasts for 7 days or until transfer out of the intensive care unit (ICU).
length of hospital stay, and ICU length of stay
Time frame: The observation period starts from patient enrollment and lasts for 7 days or until transfer out of the intensive care unit (ICU).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Individual participant dataSharing planned: Yes. all collected IPD，all IPD that underlie results in a publication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shu Li, doctor principal investigator
Peking University People's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Patients With Moderate to Severe Pain Requiring Analgesic Medications, run by Peking University People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shu Li, doctor (+86 010 88324480, lishu2401@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of time points achieving the target analgesic score range among all time points. (time frame: The observation period starts from patient enrollment and lasts for 7 days or until transfer out of the intensive care unit (ICU).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2025.