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

Sponsor

University College Dublin (Other)

Overall Status

Completed

CT.gov ID

NCT02885948

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

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 :

Apr 1, 2016

Actual Primary Completion Date :

Dec 1, 2017

Actual Study Completion Date :

Dec 1, 2017

Arms and Interventions

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 Names: Placebo Saline

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 Names:

Placebo Saline

Outcome Measures

Primary Outcome Measures

Respiratory depression [within 16 - 24 hours of participation]

Secondary Outcome Measures

Measure of occurrence of pain [within 16 - 24 hours of participation]
Requirement for rescue analgesia [within 16 - 24 hours of participation]
Nausea/Vomiting [within 16 - 24 hours of participation]
Pruritus [within 16 - 24 hours of participation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Prof. Alistair Nichol	Dublin		Ireland	Dublin 4

Sponsors and Collaborators

University College Dublin

Investigators

Study Director: Peter Doran, PhD, UCD

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University College Dublin

ClinicalTrials.gov Identifier:

NCT02885948

Other Study ID Numbers:

UCDCRC/15/006

First Posted:

Sep 1, 2016

Last Update Posted:

Dec 19, 2017

Last Verified:

Dec 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Additional relevant MeSH terms:

Respiratory Insufficiency

Depression

Depressive Disorder

Naloxone

Study Results

No Results Posted as of Dec 19, 2017