DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Use of Intrathecal Hydromorphone in Elective Cesarean Deliveries

Information source: University of Kansas
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain

Intervention: Hydromorphone (Drug); Morphine (Drug)

Phase: Phase 0

Status: Recruiting

Sponsored by: Grace Shih, MD

Official(s) and/or principal investigator(s):
Grace Shih, MD, Principal Investigator, Affiliation: University of Kansas

Overall contact:
Stephanie Thomas-Dodson, RN, BSN, Phone: (913) 588-0057, Email: sthomas-dodson@kumc.edu

Summary

The purpose of this study is to determine if intrathecal hydromorphone will relieve pain as well as intrathecal morphine after cesarean delivery, with fewer side effects.

Clinical Details

Official title: Use of Intrathecal Hydromorphone in Elective Cesarean Deliveries

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: Change in Pain Scores

Secondary outcome: Number of Participants with Adverse Events (AEs)

Detailed description: Intrathecal morphine has long been the standard pain medication used in cesarean sections. Since some patients cannot tolerate morphine, hydromorphone may be an acceptable alternative. Intrathecal Intrathecal hydromorphone has been shown to be effective at treating post cesarean section pain and possibly with less side effects than morphine. One side effect of morphine is respiratory depression occurring hours after the start of morphine use. Respiratory depression occurs when air being taken into the lungs is less than normal, leading to a lower amount of oxygen and carbon dioxide being exchanged in the blood stream. Because hydromorphone dosages are lower and it has a quicker onset of action than morphine, it is believed that the use of hydromorphone should decrease the possibility of delayed respiratory depression.

Eligibility

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Scheduled for elective Cesarean sections under spinal anesthesia or combined spinal

anesthesia

- ASA status of I-III

- BMI < 40

- Able to understand and sign informed consent

Exclusion Criteria:

- Severe pre-eclampsia

- Conversion to general anesthetic

- History of chronic opioid use

- Allergy to morphine, or hydromorphone

- Hyperemesis gravidarum

- Emergency case

- Patients who have an infection at the intended site of spinal insertion

Locations and Contacts

Stephanie Thomas-Dodson, RN, BSN, Phone: (913) 588-0057, Email: sthomas-dodson@kumc.edu

University of Kansas Medical Center, Kansas City, Kansas 66160, United States; Recruiting
Katherine Stiles, MD, Sub-Investigator
Martin DeRuyter, MD, Sub-Investigator
Stephanie Thomas-Dodson, RN, BSN, Sub-Investigator
Additional Information

Starting date: May 2013
Last updated: June 25, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017