The Use of Low Dose Prophylactic Naloxone Infusion to Prevent Respiratory Depression With Intrathecal Morphine. (NAPRESSIM)
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|ClinicalTrials.gov Identifier: NCT02885948|
Recruitment Status : Completed
First Posted : September 1, 2016
Last Update Posted : December 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Depression||Drug: Naloxone Drug: Placebo||Phase 4|
Delayed respiratory depression is a well-documented side effect associated with the use of intrathecal morphine. This respiratory depression has implications for patient safety and necessitates either the observation of the patient in a high dependency setting for at least 24 hours or the use of an alternative analgesic technique. Other associated side effects include pruritus, nausea and vomiting and sedation. Naloxone is the most effective treatment for these side effects. However, it is usually given as a reactive treatment when the side effect presents.
The hypothesis is that patients who are commenced on a naloxone infusion at low dose early after injection of intrathecal morphine will have a clinically significant reduction in incidence of these side effects. The primary endpoint is a reduction in respiratory depression.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||96 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The NAPRESSIM Trial. The Use of Low Dose Prophylactic Naloxone Infusion to Prevent Respiratory Depression With Intrathecal Morphine.|
|Study Start Date :||April 2016|
|Actual Primary Completion Date :||December 2017|
|Actual Study Completion Date :||December 2017|
The naloxone arm of the study will receive naloxone at a rate of 5mcg/kg/hr which equates to 0.25ml/kg/hr. Each 1 ml ampoule of solution contains 400 micrograms (0.4mg) naloxone hydrochloride present as naloxone hydrochloride dihydrate.
Excipients: each 1ml contains 3.55mg sodium. This will be diluted to a concentration of 20mcg/ml with 0.9% NaCl. Presented as solution for injection or infusion. Clear colourless sterile solution.
used to block the effects of opioids, especially in overdose
Placebo Comparator: Saline
The placebo arm of the study will receive an infusion of normal saline at a rate of 0.25ml/kg/hr.
Placebo, ineffective control arm
Other Name: Placebo Saline
- Respiratory depression [ Time Frame: within 16 - 24 hours of participation ]
- Measure of occurrence of pain [ Time Frame: within 16 - 24 hours of participation ]
- Requirement for rescue analgesia [ Time Frame: within 16 - 24 hours of participation ]
- Nausea/Vomiting [ Time Frame: within 16 - 24 hours of participation ]
- Pruritus [ Time Frame: within 16 - 24 hours of participation ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02885948
|Prof. Alistair Nichol|
|Dublin, Ireland, Dublin 4|
|Study Director:||Peter Doran, PhD||UCD|