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The Use of Low Dose Prophylactic Naloxone Infusion to Prevent Respiratory Depression With Intrathecal Morphine. (NAPRESSIM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02885948
Recruitment Status : Completed
First Posted : September 1, 2016
Last Update Posted : December 19, 2017
Information provided by (Responsible Party):
University College Dublin

Brief Summary:
This is an investigator led, randomised, double blind, placebo controlled, double arm comparator study.

Condition or disease Intervention/treatment Phase
Respiratory Depression Drug: Naloxone Drug: Placebo Phase 4

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Naloxone

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.

Drug: Naloxone
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.
Drug: Placebo
Placebo, ineffective control arm
Other Name: Placebo Saline

Primary Outcome Measures :
  1. Respiratory depression [ Time Frame: within 16 - 24 hours of participation ]

Secondary Outcome Measures :
  1. Measure of occurrence of pain [ Time Frame: within 16 - 24 hours of participation ]
  2. Requirement for rescue analgesia [ Time Frame: within 16 - 24 hours of participation ]
  3. Nausea/Vomiting [ Time Frame: within 16 - 24 hours of participation ]
  4. Pruritus [ Time Frame: within 16 - 24 hours of participation ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects must be aged 18 years or above at baseline
  • Diagnosed with any hepatobiliary condition requiring an elective major surgical resection under general anaesthetic.
  • Subjects must be able and willing to give written informed consent and to comply with the requirements of this study protocol

Exclusion Criteria:

  • Allergy/sensitivity to naloxone
  • Female subjects who are pregnant or breast-feeding.
  • Subjects who have received any other investigational agent within 2 months
  • Subjects taking anticonvulsant medications for epilepsy
  • Subjects who have a cardiac arrhythmia with an uncontrolled rate
  • Subjects who have a history of chronic opioid use / chronic pain
  • Any contraindication to intrathecal injection eg coagulopathy
  • Documented history of obstructive sleep apnoea
  • Treating clinician feels not in the patients best interests to be randomised

Information from the National Library of Medicine

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 identifier (NCT number): NCT02885948

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Prof. Alistair Nichol
Dublin, Ireland, Dublin 4
Sponsors and Collaborators
University College Dublin
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Study Director: Peter Doran, PhD UCD
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University College Dublin Identifier: NCT02885948    
Other Study ID Numbers: UCDCRC/15/006
First Posted: September 1, 2016    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Respiratory Insufficiency
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Respiration Disorders
Respiratory Tract Diseases
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents