We have located links that may give you full text access.
CLINICAL TRIAL, PHASE II
JOURNAL ARTICLE
Determination of ED50 and time to effectiveness for intrathecal hydromorphone in laboring patients using Dixon's up-and-down sequential allocation method.
BMC Anesthesiology 2018 October 6
BACKGROUND: With the increasing occurrence of drug shortages, understanding the pharmacokinetics of alternative intrathecal opioid administration has gained importance. In particular, additional data are needed to comprehensively evaluate the analgesic properties of intrathecal hydromorphone in the laboring patient. In a phase 2 clinical trial, we set out to determine the median effective dose (ED50 ) and time to effectiveness for this drug in this population.
METHODS: Using Dixon's up-and-down sequential allocation method, twenty women presenting for labor analgesia were prospectively enrolled. A combined spinal-epidural technique was used to deliver the determined dose of intrathecal hydromorphone. Visual analog pain scores were obtained assessing peak pain scores during serial uterine contractions. Effective pain relief was defined as achieving a pain score of less than or equal to 3 out of 10. The dose was deemed to be ineffective if the patient failed to achieve this level of relief after 30 min.
RESULTS: The ED50 of hydromorphone in our population was 10.9 μg (95% confidence interval 5.6-16.2 μg). Amongst patients for whom the dose was effective, the median time to pain relief was 24 min. One patient experienced both nausea and pruritus. No other complications were noted.
CONCLUSION: Due to the prolonged time to onset, hydromorphone cannot be recommended in favor of substantively better alternatives such as sufentanil and fentanyl.
TRIAL REGISTRATION: Clinicaltrials.gov registration number: NCT01598506.
METHODS: Using Dixon's up-and-down sequential allocation method, twenty women presenting for labor analgesia were prospectively enrolled. A combined spinal-epidural technique was used to deliver the determined dose of intrathecal hydromorphone. Visual analog pain scores were obtained assessing peak pain scores during serial uterine contractions. Effective pain relief was defined as achieving a pain score of less than or equal to 3 out of 10. The dose was deemed to be ineffective if the patient failed to achieve this level of relief after 30 min.
RESULTS: The ED50 of hydromorphone in our population was 10.9 μg (95% confidence interval 5.6-16.2 μg). Amongst patients for whom the dose was effective, the median time to pain relief was 24 min. One patient experienced both nausea and pruritus. No other complications were noted.
CONCLUSION: Due to the prolonged time to onset, hydromorphone cannot be recommended in favor of substantively better alternatives such as sufentanil and fentanyl.
TRIAL REGISTRATION: Clinicaltrials.gov registration number: NCT01598506.
Full text links
Related Resources
Trending Papers
Heart failure with preserved ejection fraction: diagnosis, risk assessment, and treatment.Clinical Research in Cardiology : Official Journal of the German Cardiac Society 2024 April 12
Proximal versus distal diuretics in congestive heart failure.Nephrology, Dialysis, Transplantation 2024 Februrary 30
Efficacy and safety of pharmacotherapy in chronic insomnia: A review of clinical guidelines and case reports.Mental Health Clinician 2023 October
World Health Organization and International Consensus Classification of eosinophilic disorders: 2024 update on diagnosis, risk stratification, and management.American Journal of Hematology 2024 March 30
Get seemless 1-tap access through your institution/university
For the best experience, use the Read mobile app
All material on this website is protected by copyright, Copyright © 1994-2024 by WebMD LLC.
This website also contains material copyrighted by 3rd parties.
By using this service, you agree to our terms of use and privacy policy.
Your Privacy Choices
You can now claim free CME credits for this literature searchClaim now
Get seemless 1-tap access through your institution/university
For the best experience, use the Read mobile app