Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06444997
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-05-24
Brief Title:
Efficacy and Safety of Oxycodone Hydrochloride for Long-term Analgesia in ICU Patients
Sponsor:
Shanghai Zhongshan Hospital
Organization:
Shanghai Zhongshan Hospital
Study Overview
Official Title:
Efficacy and Safety of Oxycodone Hydrochloride and Remifentanil for Long-term Analgesia During Invasive Mechanical Ventilation in Postoperative Patients A Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn if oxycodone hydrochloride works to manage pain in patients requiring mechanical ventilation It will also assess the safety of oxycodone hydrochloride The main questions it aims to answer are
1 Does oxycodone hydrochloride effectively lower the CPOT Critical Care Pain Observation Tool score in mechanically ventilated patients
2 What medical problems do participants have when using oxycodone hydrochloride Researchers will compare oxycodone hydrochloride to remifentanil to see if oxycodone works better to manage pain in these patients
Participants will
Receive either oxycodone hydrochloride injection at a dose of 003-02 mgkgh or remifentanil injection at a dose of 2-9 μgkgh
Have their pain scores assessed every 15 minutes until the CPOT score is less than 3 After reaching the target pain score assessments will be done every 4 hours
Have their vital signs and monitoring data recorded
Have analgesia and sedation scores recorded from days 1 to 7 after administration with drug dosages adjusted based on pain scores
Have the incidence of adverse reactions and changes in gastrointestinal function observed and recorded from days 1 to 7 after administration
If extubated within 7 days relevant data will be collected based on the time of extubation
Be followed up on day 28 through the electronic medical record system to gather data on the extubation success rate and incidence of complications within the 28-day period
1 Does oxycodone hydrochloride effectively lower the CPOT Critical Care Pain Observation Tool score in mechanically ventilated patients
2 What medical problems do participants have when using oxycodone hydrochloride Researchers will compare oxycodone hydrochloride to remifentanil to see if oxycodone works better to manage pain in these patients
Participants will
Receive either oxycodone hydrochloride injection at a dose of 003-02 mgkgh or remifentanil injection at a dose of 2-9 μgkgh
Have their pain scores assessed every 15 minutes until the CPOT score is less than 3 After reaching the target pain score assessments will be done every 4 hours
Have their vital signs and monitoring data recorded
Have analgesia and sedation scores recorded from days 1 to 7 after administration with drug dosages adjusted based on pain scores
Have the incidence of adverse reactions and changes in gastrointestinal function observed and recorded from days 1 to 7 after administration
If extubated within 7 days relevant data will be collected based on the time of extubation
Be followed up on day 28 through the electronic medical record system to gather data on the extubation success rate and incidence of complications within the 28-day period
Detailed Description:
This study is a single-center single-blind randomized controlled exploratory study involving subjects aged 18 to 80 who are expected to require mechanical ventilation for 24 hours and who were intubated and received mechanical ventilation for less than 3 days before enrollment Subjects will be treated with either oxycodone hydrochloride injection or remifentanil injection and will be randomly assigned in a 11 ratio giving each subject a 50 chance of being assigned to the control group
Trial Group Subjects will receive oxycodone hydrochloride injection at a dose of 003-02 mgkgh Pain scores will be assessed every 15 minutes until the CPOT Critical Care Pain Observation Tool score is less than 3 After achieving the target pain score pain scores will be assessed every 4 hours
Control Group Subjects will receive remifentanil hydrochloride injection at a dose of 2-9 μgkgh Pain scores will be assessed every 15 minutes until the CPOT score is less than 3 After achieving the target pain score pain scores will be assessed every 4 hours
During this period the vital signs and monitoring data of the subjects will be recorded Analgesia and sedation scores will be recorded from days 1 to 7 after administration and the analgesic and sedative drug dosages will be adjusted based on the subjects pain scores Additionally the incidence of adverse reactions and changes in gastrointestinal function will be observed and recorded from days 1 to 7 after administration
There are no biological detection indicators in this study all evaluations are made by the researchers through scoring sheets and will not affect the subjects normal treatment If a subject is extubated and weaned off the ventilator within 7 days relevant data will be collected based on the time of extubation On the 28th day after administration doctors will follow up via the electronic medical record system to gather data on the extubation success rate incidence of complications and other relevant indicators within the 28-day period
Trial Group Subjects will receive oxycodone hydrochloride injection at a dose of 003-02 mgkgh Pain scores will be assessed every 15 minutes until the CPOT Critical Care Pain Observation Tool score is less than 3 After achieving the target pain score pain scores will be assessed every 4 hours
Control Group Subjects will receive remifentanil hydrochloride injection at a dose of 2-9 μgkgh Pain scores will be assessed every 15 minutes until the CPOT score is less than 3 After achieving the target pain score pain scores will be assessed every 4 hours
During this period the vital signs and monitoring data of the subjects will be recorded Analgesia and sedation scores will be recorded from days 1 to 7 after administration and the analgesic and sedative drug dosages will be adjusted based on the subjects pain scores Additionally the incidence of adverse reactions and changes in gastrointestinal function will be observed and recorded from days 1 to 7 after administration
There are no biological detection indicators in this study all evaluations are made by the researchers through scoring sheets and will not affect the subjects normal treatment If a subject is extubated and weaned off the ventilator within 7 days relevant data will be collected based on the time of extubation On the 28th day after administration doctors will follow up via the electronic medical record system to gather data on the extubation success rate incidence of complications and other relevant indicators within the 28-day period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None