Pain Calculator for Pain Management
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method for managing pain in individuals undergoing certain gynecologic procedures, such as IUD insertion or an endometrial biopsy. Researchers aim to determine if a risk-stratification calculator can better predict and manage severe pain by customizing pain medications according to each person’s risk level. Participants will receive pain management either through this risk-stratification calculator or based on their provider's best judgment. Those who speak English, have access to a smart device, and are scheduled for one of the specified procedures may be suitable for this trial. As an unphased trial, this study allows participants to contribute to innovative pain management strategies that could enhance future care.
Will I have to stop taking my current medications?
If you are taking methadone, Suboxone, or naltrexone, you cannot participate in the trial. The protocol does not specify if you need to stop other medications, so it's best to discuss with the trial team.
What prior data suggests that this risk-stratification calculator is safe for pain management?
Research shows that using a tool to assess pain risk is a promising method. This tool determines the likelihood of a patient experiencing severe pain during procedures and suggests appropriate pain medications. Although specific safety data from this trial is not yet available, similar tools have been used safely in other medical settings. For instance, the Veterans Health Administration employs a similar tool to manage opioid risks, focusing on patient safety and effective pain control.
These tools guide medication choices based on each person's risk, aiming to manage pain effectively without overusing medication. This approach is generally well-received because it tailors treatment to the individual. However, discussing any concerns or questions with the healthcare team conducting the trial is always important.12345Why are researchers excited about this trial?
Researchers are excited about the Pain Calculator for pain management because it offers a personalized approach to pain treatment. Unlike standard care, which often relies on a provider's general judgment, this method uses a Risk-Stratification Calculator to assess an individual's risk of severe pain. By tailoring pain medication based on this risk level, it aims to enhance pain management efficiency and effectiveness. This innovative approach could lead to more precise and effective pain relief for patients, potentially reducing both over-treatment and under-treatment of pain.
What evidence suggests that using a risk-stratification calculator is effective for pain management during in-office gynecologic procedures?
In this trial, participants will join one of two groups. One group will use a Pain Calculator, an experimental tool that assesses their risk—low, moderate, or high—for severe pain during their procedure, with pain medications assigned accordingly. Previous research has shown that risk-stratification calculators effectively assess patients' pain levels. For example, the Opioid Risk Tool has proven effective in identifying the risk of severe pain and potential opioid misuse, aiding doctors in selecting the right pain management plan. The Veterans Health Administration has used a similar tool to make opioid prescribing safer, reducing overdose and suicide risks. These tools suggest that using a calculator to determine pain medication based on risk could improve pain management and increase patient satisfaction during procedures.15678
Who Is on the Research Team?
Georgina Cheng, MD PhD
Principal Investigator
Carle Foundation Hospital
Beverly London, MD
Principal Investigator
Carle Foundation Hospital
Are You a Good Fit for This Trial?
This trial is for patients undergoing in-office gynecologic procedures who are willing to have their pain managed either by a risk-stratification calculator or their provider's best judgment. Participants must also be comfortable completing an online survey about their experience.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Procedure and Treatment
Participants undergo in-office gynecologic procedures and receive pain medications based on risk-stratification calculator or provider's judgement
Follow-up
Participants complete an online survey about their experience and pain management
What Are the Treatments Tested in This Trial?
Interventions
- Pain Management using Risk-Stratification Calculator
Trial Overview
The study tests if using a pain calculator to prescribe medications can improve pain scores and patient satisfaction during gynecologic procedures, compared to providers' best judgment. It involves answering questions that assess the risk of severe pain and then receiving medication based on those answers.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants will answer the Pain Calculator Questionnaire that will determine if they are low, moderate, or high risk for severe pain during their procedure. They will receive assigned pain medications based on their risk.
Participants will have their pain management determined by the provider's best judgement, using shared decision making
Find a Clinic Near You
Who Is Running the Clinical Trial?
Carle Foundation Hospital
Lead Sponsor
Citations
Pain Management for In-Office Gynecologic Procedures ...
The goal of this clinical trial is to learn how using a risk-stratification calculator to determine the risk of a patient experiencing severe ...
Opioid, Risk Tool - StatPearls - NCBI Bookshelf
The Opioid Risk Tool (ORT) is a validated screening instrument commonly used in practice to evaluate the risk of future aberrant opioid use.
Stratification Tool for Opioid Risk Mitigation (STORM) - PEPReC
In response to concerns about opioid safety, the Veterans Health Administration (VHA) developed and mandated the use of the Stratification Tool for Opioid Risk ...
4.
psnet.ahrq.gov
psnet.ahrq.gov/innovation/veterans-health-administration-stratification-tool-opioid-risk-mitigation-storm-showsVeterans Health Administration Stratification Tool for Opioid ...
This innovation focuses on mitigating overdose and suicide risks associated with opioid prescribing to veterans by providing clinicians information.
5.
my.clevelandclinic.org
my.clevelandclinic.org/departments/anesthesiology/depts/outcomes-research/risk-stratificationRisk Stratification Index
Learn about Risk Stratification Methodology, a nationally validated source, that permits outcomes to be compared equally across institutions.
Pain Calculator for Pain Management · Info for Participants
The goal of this clinical trial is to learn how using a risk-stratification calculator to determine the risk of a patient experiencing ...
Pain Management for In-Office Gynecologic Procedures ...
The goal of this clinical trial is to learn how using a risk-stratification calculator to determine the risk of a patient experiencing severe pain during an ...
Testing the Decision Support Tool for Responsible Pain ...
Testing the Decision Support Tool for Responsible Pain Management for Headache and Facial Pain Diagnosis with Opioid-Risk-Stratified Treatment.
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