Adjuvant Continuous Infusion of Nefopam Versus Standard of Care in Mechanically Ventilated Critically Ill Patients: Randomized Double-blind Controlled Study

NCT05071352 | Completed Phase 3

• 1 other identifier: Nefopam
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this prospective, randomized, active control, double blinded study is to assess the effect and safety of continuous infusion nefopam in mechanically ventilated ICU patients compared to standard of care. It is being hypothesized that continuous infusion nefopam will reduce opioid use with acceptable safety profile compared to standard of care.

Conditions

Analgesia; Critical Illness; Mechanical Ventilation; Sedation

Keywords

Nefopam, Ketamine, Standard of care, Sedation, Critically ill, Mechanical ventilation, Propofol, Fentanyl, Midazolam, Delirium, Vasopressors.

Outcome Measures

Primary Outcomes (1)

• Cumulative dose of fentanyl

  To compare the cumulative dose of fentanyl

  First 24 hour after randomization.

Secondary Outcomes (14)

• Richmond Agitation and Sedation Score (RASS)

  First 24 hours after randomization.

• pain score

  First 24 hours after randomization.

• Duration of mechanical ventilation (MV)

  The number of calendar days from intubation date to extubation date, until ICU discharge, death, or 28 days post-randomization, whichever comes first.

• vasopressor requirements

  First 24 hours after randomization.

• Hemodynamics

  First 24 hours after randomization.

Study Arms (2)

Nefopam group

EXPERIMENTAL

Adjunct continuous infusion of nefopam plus standard of care in ICU for assessment and management of pain, sedation, and delirium. Nefopam will be administered as an initial dose of 20 mg IV dose infused over 15 minutes then, as continuous infusion of 5 mg/hr for 24 hours.

Drug: Nefopam; Drug: Standard of care in the ICU for assessment and management of pain, sedation, and delirium.

Control group

PLACEBO COMPARATOR

Standard of care in the ICU for assessment and management of pain, sedation, and delirium.

Drug: Standard of care in the ICU for assessment and management of pain, sedation, and delirium.

Interventions

Nefopam DRUG

Nefopam will be administered as an initial dose of 20 mg IV dose infused over 15 minutes then, as continuous infusion of 5 mg/hr for 24 hours.

Also known as: Acupan

Nefopam group

Standard of care in the ICU for assessment and management of pain, sedation, and delirium. DRUG

In our protocol we use analgiosedation approach (an opioid is used before a sedative to reach the sedation goal), targeting light sedation using richmond agitation sedation scale (RASS) score -1 to 0, and assess delirium using confusion assessment method for the ICU (CAM-ICU).

Also known as: Standard of care

Control group; Nefopam group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients \>18 years on mechanical ventilation and expected to need ventilatory support for the next 24 hours.
• Candidate for sedation and analgesia protocol

You may not qualify if:

• Pregnant and/or lactating woman.
• Has been intubated for duration longer than 12 hours in an intensive care unit.
• Proven or suspected acute primary brain lesion such as traumatic brain injury, intracranial haemorrhage, stroke, or hypoxic brain injury.
• Proven or suspected spinal cord injury or other pathology that may result in permanent or prolonged weakness.
• Admission as a consequence of a suspected or proven drug overdose
• Mean arterial pressure (MAP) \< 50 mmHg despite adequate resuscitation and vasopressor therapy at time of randomization.
• Death is deemed to be imminent or inevitable during this admission and either the attending physician, patient or substitute decision maker is not committed to active treatment.
• Patients with severe hepatic impairment (Child-Pugh class C) or end stage renal disease (ESRD) (creatinine clearance \< 30 ml/min or on chronic hemodialysis) due to altered pharmacokinetics \[20\].
• Need for deep sedation such as administration of neuromuscular blockers.
• Convulsions or previous history of convulsions.
• Risk of urinary retention linked to uretroprostatic disorders.
• Risk of acute angle glaucoma.
• Known intolerance of or hypersensitivity to study medications or constituents.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University Hospitals (Kasr Alainy)

Cairo, Egypt

Location

Related Publications (23)

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  PMID: 40250620 DERIVED

MeSH Terms

Conditions

Agnosia; Critical Illness; Delirium

Interventions

Nefopam; Standard of Care; Restraint, Physical

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes; Confusion; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Oxazocines; Azocines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Mohammed Gamal Abdelraouf Amer, Pharm D

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Reseacher

Study Record Dates

• First Submitted: September 4, 2021
• First Posted: October 8, 2021
• Study Start: October 1, 2021
• Primary Completion: March 1, 2023
• Study Completion: March 31, 2023
• Last Updated: December 19, 2025

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)