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

Respiratory Depression Clinical Trial

— NAPRESSIM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02885948
• Other study ID #: UCDCRC/15/006
• Status: Completed
• Phase: Phase 4
• First received: July 4, 2016
• Last updated: December 17, 2017
• Start date: April 2016
• Est. completion date: December 2017

Study information

• Verified date: December 2017
• Source: University College Dublin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Respiratory Depression
• Respiratory Insufficiency

Intervention

Drug:
• Naloxone
used to block the effects of opioids, especially in overdose
• Placebo
Placebo, ineffective control arm

Locations

Country	Name	City	State
Ireland	Prof. Alistair Nichol	Dublin

Sponsors (1)

Lead Sponsor	Collaborator
University College Dublin

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory depression		within 16 - 24 hours of participation
Secondary	Measure of occurrence of pain		within 16 - 24 hours of participation
Secondary	Requirement for rescue analgesia		within 16 - 24 hours of participation
Secondary	Nausea/Vomiting		within 16 - 24 hours of participation
Secondary	Pruritus		within 16 - 24 hours of participation