AnalgesiaPhase 3NCT05071352
Adjuvant Continuous Infusion of Nefopam Versus Standard of Care in Mechanically Ventilated Critically Ill Patients: Randomized Double-blind Controlled Study
A Phase 3 study testing Nefopam in people with Analgesia and Critical Illness, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Analgesia, Critical Illness, Mechanical Ventilation
- What is being tested?
- Nefopam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2021to 31 Mar 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients >18 years on mechanical ventilation and expected to need ventilatory support for the next 24 hours.
- Candidate for sedation and analgesia protocol
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Pain is defined as "an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage". Critically ill patients experience pain at rest and during standard caring procedures. Arterial catheter insertion, chest tube removal, wound drain removal, wound care, and turning are associated with the greatest increased pain intensity. Pain have short and long-term sequelae on critically ill patients. Short-term sequelae include impaired tissue oxygenation, impaired wound healing, and impaired immune functions. Long-term sequelae include chronic pain, Post-traumatic stress disorder (PTSD) symptoms, and a lower health-related quality of life.
The gold standard for pain assessment is patient's self-report of pain. For critically ill able to self-report pain the 0-10 numeric rating scale in a visual format (NRS-V) is the best to use. Unfortunately, a lot of critically ill patients are unable to communicate and self-report pain. So, using behavioral pain scales are suitable in this type of patients, Critical care pain observation tool (CPOT) demonstrates validity and reliability for monitoring pain in critical ill adult patient who are unable to self-report pain and in whom behaviors are observable. The 2018 Pain, Agitation/sedation, Delirium, Immobility, and Sleep disruption (PADIS) guideline panel suggests "using an assessment-driven, protocol-based, stepwise approach for pain and sedation management in critically ill adults" and state as a good practice statement "critically ill adults should be regularly assessed for delirium using a valid tool".
Opioids are a cornerstone in the management of pain in critically ill patient, but have a lot of negative consequences including constipation, urinary retention, bronchospasm, over-sedation, respiratory depression, hypotension, nausea, truncal rigidity, delirium, and immunosuppression. Also, they contribute to vasodilatation and hypotension which lead to increased resuscitation fluids volume in critically ill patient.
"Multi-modal analgesia" also known as "balanced analgesia" approach via using non-opioids adjuvant or in replacement of opioids to target different pain pathways leads to optimizing analgesia and reducing opioids consumption. In France, the second most prescribed non-opioids in mechanically ventilated intensive care unit (ICU) patient is nefopam. Nefopam is a non-opioid, non-steroidal centrally acting analgesic, although the exact mechanism of action poorly understood, analgesic activity is thought to be via inhibiting dopamine, norepinephrine, serotonin reuptake. Nefopam was non-inferior to fentanyl for pain control in patients undergoing elective cardiac surgery without increase in adverse effects. Nefopam has a fentanyl sparing effect up to 50% in patients underwent laparoscopic total hysterectomy.
The 2018 PADIS guideline panel made a conditional recommendation for using "nefopam (if feasible) either as an adjunct or replacement for an opioid to reduce opioid use and their safety concerns for pain management in critically ill adults".
Therefore, 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
- Being tested
- Nefopam, Standard of care in the ICU for assessment and management of pain, sedation, and delirium.
- Keywords
- Nefopam, Ketamine, Standard of care, Sedation, Critically ill, Mechanical ventilation, Propofol, Fentanyl, Midazolam, Delirium, Vasopressors.
- Medical subject headings
- Agnosia, Critical Illness, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NefopamDrug
Also called Acupan
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.
Standard of care in the ICU for assessment and management of pain, sedation, and delirium.Drug
Also called Standard of care
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Standard of care in the ICU for assessment and management of pain, sedation, and delirium. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative dose of fentanyl
To compare the cumulative dose of fentanyl
Measured: First 24 hour after randomization.
Secondary outcomes (14)
Richmond Agitation and Sedation Score (RASS)
To compare number of patients are in RASS score goal. RASS score minumum -5 (unarousable), maximun +4 (Combative). Goal RASS score from -1 (drowsy) to 0 (alert and calm).
Measured: First 24 hours after randomization.
pain score
To compare number of patients are in Pain score goal. If patient able to communicate we use the 0-10 numeric rating scale in a visual format (NRS-V), 0 indicate no pain and 10 indicate the worst pain imaginable.
For patient unable to communicate we use Critical care pain observation tool (CPOT) score, a score ≥3 indicate significant pain.
Measured: First 24 hours after randomization.
Duration of mechanical ventilation (MV)
To assess whether nefopam can help to shorten the of being mechanically ventilated.
Measured: 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
To compare vasopressors requirement
Measured: First 24 hours after randomization.
Hemodynamics
changes in Mean Arterial Pressure (MAP) mmHg
Measured: First 24 hours after randomization.
Hemodynamics
changes in Heart Rate (HR) beats/minute.
Measured: First 24 hours after randomization.
ICU length of stay (LOS)
To compare ICU LOS
Measured: From randomization to ICU discharge date
Tracheostomy
Tracheostomy rate
Measured: 28 days post-randomization
Unplanned extubation (self-extubation)
Unplanned extubation date rate
Measured: 28 days post-randomization
Re-intubation
Re-intubation rate
Measured: 28 days post-randomization
Incidence of delirium
Rate of positive confusion assessment method for the ICU (CAM-ICU) score
Measured: 24 hour after randomization
Use of antipsychotics
Rate of using antipsychotics for confirmed ICU-acquired delirium
Measured: 24 hour after randomization
Use of physical restraint
Use of physical restraint
Measured: 24 hour after randomization
Mortality rate at the time of hospital discharge or 28 days after randomization, whichever comes first.
Mortality rate at the time of hospital discharge or 28 days after randomization, whichever comes first.
Measured: 28 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start1 Oct 2021
- Primary completion1 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Gamal Abdelraouf Amer, Cairo University
- Investigators
- Mohammed Gamal Abdelraouf Amer, Pharm D, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05071352
- Sponsor's protocol ID
- Nefopam
- Status last verified
- Feb 2023
- First submitted
- 4 Sep 2021
- Last updated
- 19 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Loeser JD, Treede RD. The Kyoto protocol of IASP Basic Pain Terminology. Pain. 2008 Jul 31;137(3):473-477. doi: 10.1016/j.pain.2008.04.025. Epub 2008 Jun 25. No abstract available.
PubMed 18583048Chanques G, Sebbane M, Barbotte E, Viel E, Eledjam JJ, Jaber S. A prospective study of pain at rest: incidence and characteristics of an unrecognized symptom in surgical and trauma versus medical intensive care unit patients. Anesthesiology. 2007 Nov;107(5):858-60. doi: 10.1097/01.anes.0000287211.98642.51. No abstract available.
PubMed 18073576Puntillo KA, Max A, Timsit JF, Vignoud L, Chanques G, Robleda G, Roche-Campo F, Mancebo J, Divatia JV, Soares M, Ionescu DC, Grintescu IM, Vasiliu IL, Maggiore SM, Rusinova K, Owczuk R, Egerod I, Papathanassoglou ED, Kyranou M, Joynt GM, Burghi G, Freebairn RC, Ho KM, Kaarlola A, Gerritsen RT, Kesecioglu J, Sulaj MM, Norrenberg M, Benoit DD, Seha MS, Hennein A, Periera FJ, Benbenishty JS, Abroug F, Aquilina A, Monte JR, An Y, Azoulay E. Determinants of procedural pain intensity in the intensive care unit. The Europain(R) study. Am J Respir Crit Care Med. 2014 Jan 1;189(1):39-47. doi: 10.1164/rccm.201306-1174OC.
PubMed 24262016Chapman CR, Tuckett RP, Song CW. Pain and stress in a systems perspective: reciprocal neural, endocrine, and immune interactions. J Pain. 2008 Feb;9(2):122-45. doi: 10.1016/j.jpain.2007.09.006. Epub 2007 Dec 21.
PubMed 18088561Tennant F. The physiologic effects of pain on the endocrine system. Pain Ther. 2013 Dec;2(2):75-86. doi: 10.1007/s40122-013-0015-x. Epub 2013 Aug 20.
PubMed 25135146Sigakis MJ, Bittner EA. Ten Myths and Misconceptions Regarding Pain Management in the ICU. Crit Care Med. 2015 Nov;43(11):2468-78. doi: 10.1097/CCM.0000000000001256.
PubMed 26308433Chanques G, Viel E, Constantin JM, Jung B, de Lattre S, Carr J, Cisse M, Lefrant JY, Jaber S. The measurement of pain in intensive care unit: comparison of 5 self-report intensity scales. Pain. 2010 Dec;151(3):711-721. doi: 10.1016/j.pain.2010.08.039. Epub 2010 Sep 16.
PubMed 20843604Devlin JW, Skrobik Y, Gelinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299.
PubMed 30113379Gelinas C, Fillion L, Puntillo KA, Viens C, Fortier M. Validation of the critical-care pain observation tool in adult patients. Am J Crit Care. 2006 Jul;15(4):420-7.
PubMed 16823021Benyamin R, Trescot AM, Datta S, Buenaventura R, Adlaka R, Sehgal N, Glaser SE, Vallejo R. Opioid complications and side effects. Pain Physician. 2008 Mar;11(2 Suppl):S105-20.
PubMed 18443635Wibbenmeyer L, Sevier A, Liao J, Williams I, Light T, Latenser B, Lewis R 2nd, Kealey P, Rosenquist R. The impact of opioid administration on resuscitation volumes in thermally injured patients. J Burn Care Res. 2010 Jan-Feb;31(1):48-56. doi: 10.1097/BCR.0b013e3181c7ed30.
PubMed 20061837Kohler M, Chiu F, Gelber KM, Webb CA, Weyker PD. Pain management in critically ill patients: a review of multimodal treatment options. Pain Manag. 2016 Nov;6(6):591-602. doi: 10.2217/pmt-2016-0002. Epub 2016 May 18.
PubMed 27188977Kumar K, Kirksey MA, Duong S, Wu CL. A Review of Opioid-Sparing Modalities in Perioperative Pain Management: Methods to Decrease Opioid Use Postoperatively. Anesth Analg. 2017 Nov;125(5):1749-1760. doi: 10.1213/ANE.0000000000002497.
PubMed 29049119Payen JF, Genty C, Mimoz O, Mantz J, Bosson JL, Chanques G. Prescribing nonopioids in mechanically ventilated critically ill patients. J Crit Care. 2013 Aug;28(4):534.e7-12. doi: 10.1016/j.jcrc.2012.10.006. Epub 2013 Mar 19.
PubMed 23522398Gregori-Puigjane E, Setola V, Hert J, Crews BA, Irwin JJ, Lounkine E, Marnett L, Roth BL, Shoichet BK. Identifying mechanism-of-action targets for drugs and probes. Proc Natl Acad Sci U S A. 2012 Jul 10;109(28):11178-83. doi: 10.1073/pnas.1204524109. Epub 2012 Jun 18.
PubMed 22711801
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Continuous Infusion of Nefopam Versus Standard of Care in Mechanically Ventilated Critically Ill Patients: Randomized Double-blind Controlled Study
- ClinicalTrials.gov ID
- NCT05071352
- Acronym / sponsor ID
- Nefopam
- Conditions
- Analgesia, Critical Illness, Mechanical Ventilation, Sedation
- Keywords
- Nefopam, Ketamine, Standard of care, Sedation, Critically ill, Mechanical ventilation, Propofol, Fentanyl, Midazolam, Delirium, Vasopressors.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 8 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Pain is defined as "an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage". Critically ill patients experience pain at rest and during standard caring procedures. Arterial catheter insertion, chest tube removal, wound drain removal, wound care, and turning are associated with the greatest increased pain intensity. Pain have short and long-term sequelae on critically ill patients. Short-term sequelae include impaired tissue oxygenation, impaired wound healing, and impaired immune functions. Long-term sequelae include chronic pain, Post-traumatic stress disorder (PTSD) symptoms, and a lower health-related quality of life.
The gold standard for pain assessment is patient's self-report of pain. For critically ill able to self-report pain the 0-10 numeric rating scale in a visual format (NRS-V) is the best to use. Unfortunately, a lot of critically ill patients are unable to communicate and self-report pain. So, using behavioral pain scales are suitable in this type of patients, Critical care pain observation tool (CPOT) demonstrates validity and reliability for monitoring pain in critical ill adult patient who are unable to self-report pain and in whom behaviors are observable. The 2018 Pain, Agitation/sedation, Delirium, Immobility, and Sleep disruption (PADIS) guideline panel suggests "using an assessment-driven, protocol-based, stepwise approach for pain and sedation management in critically ill adults" and state as a good practice statement "critically ill adults should be regularly assessed for delirium using a valid tool".
Opioids are a cornerstone in the management of pain in critically ill patient, but have a lot of negative consequences including constipation, urinary retention, bronchospasm, over-sedation, respiratory depression, hypotension, nausea, truncal rigidity, delirium, and immunosuppression. Also, they contribute to vasodilatation and hypotension which lead to increased resuscitation fluids volume in critically ill patient.
"Multi-modal analgesia" also known as "balanced analgesia" approach via using non-opioids adjuvant or in replacement of opioids to target different pain pathways leads to optimizing analgesia and reducing opioids consumption. In France, the second most prescribed non-opioids in mechanically ventilated intensive care unit (ICU) patient is nefopam. Nefopam is a non-opioid, non-steroidal centrally acting analgesic, although the exact mechanism of action poorly understood, analgesic activity is thought to be via inhibiting dopamine, norepinephrine, serotonin reuptake. Nefopam was non-inferior to fentanyl for pain control in patients undergoing elective cardiac surgery without increase in adverse effects. Nefopam has a fentanyl sparing effect up to 50% in patients underwent laparoscopic total hysterectomy.
The 2018 PADIS guideline panel made a conditional recommendation for using "nefopam (if feasible) either as an adjunct or replacement for an opioid to reduce opioid use and their safety concerns for pain management in critically ill adults".
Therefore, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nefopam group | Experimental | Drug: Nefopam, Drug: Standard of care in the ICU for assessment and management of pain, sedation, and delirium.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. |
| Control group | Placebo comparator | Drug: Standard of care in the ICU for assessment and management of pain, sedation, and delirium.Standard of care in the ICU for assessment and management of pain, sedation, and delirium. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients >18 years on mechanical ventilation and expected to need ventilatory support for the next 24 hours.
- Candidate for sedation and analgesia protocol
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NefopamAlso: AcupanNefopam 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 group |
| Standard of care in the ICU for assessment and management of pain, sedation, and delirium.Also: Standard of careIn 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). | Drug | Control group, Nefopam group |
Primary outcome
Cumulative dose of fentanyl
Time frame: First 24 hour after randomization.
To compare the cumulative dose of fentanyl
14 secondary outcomes
Richmond Agitation and Sedation Score (RASS)
Time frame: First 24 hours after randomization.
pain score
Time frame: First 24 hours after randomization.
Duration of mechanical ventilation (MV)
Time frame: 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
Time frame: First 24 hours after randomization.
Hemodynamics
Time frame: First 24 hours after randomization.
Hemodynamics
Time frame: First 24 hours after randomization.
ICU length of stay (LOS)
Time frame: From randomization to ICU discharge date
Tracheostomy
Time frame: 28 days post-randomization
Unplanned extubation (self-extubation)
Time frame: 28 days post-randomization
Re-intubation
Time frame: 28 days post-randomization
Incidence of delirium
Time frame: 24 hour after randomization
Use of antipsychotics
Time frame: 24 hour after randomization
Use of physical restraint
Time frame: 24 hour after randomization
Mortality rate at the time of hospital discharge or 28 days after randomization, whichever comes first.
Time frame: 28 days after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Background: PubMed 18583048Loeser JD, Treede RD. The Kyoto protocol of IASP Basic Pain Terminology. Pain. 2008 Jul 31;137(3):473-477. doi: 10.1016/j.pain.2008.04.025. Epub 2008 Jun 25. No abstract available.
- Background: PubMed 18073576Chanques G, Sebbane M, Barbotte E, Viel E, Eledjam JJ, Jaber S. A prospective study of pain at rest: incidence and characteristics of an unrecognized symptom in surgical and trauma versus medical intensive care unit patients. Anesthesiology. 2007 Nov;107(5):858-60. doi: 10.1097/01.anes.0000287211.98642.51. No abstract available.
- Background: PubMed 24262016Puntillo KA, Max A, Timsit JF, Vignoud L, Chanques G, Robleda G, Roche-Campo F, Mancebo J, Divatia JV, Soares M, Ionescu DC, Grintescu IM, Vasiliu IL, Maggiore SM, Rusinova K, Owczuk R, Egerod I, Papathanassoglou ED, Kyranou M, Joynt GM, Burghi G, Freebairn RC, Ho KM, Kaarlola A, Gerritsen RT, Kesecioglu J, Sulaj MM, Norrenberg M, Benoit DD, Seha MS, Hennein A, Periera FJ, Benbenishty JS, Abroug F, Aquilina A, Monte JR, An Y, Azoulay E. Determinants of procedural pain intensity in the intensive care unit. The Europain(R) study. Am J Respir Crit Care Med. 2014 Jan 1;189(1):39-47. doi: 10.1164/rccm.201306-1174OC.
- Background: PubMed 18088561Chapman CR, Tuckett RP, Song CW. Pain and stress in a systems perspective: reciprocal neural, endocrine, and immune interactions. J Pain. 2008 Feb;9(2):122-45. doi: 10.1016/j.jpain.2007.09.006. Epub 2007 Dec 21.
- Background: PubMed 25135146Tennant F. The physiologic effects of pain on the endocrine system. Pain Ther. 2013 Dec;2(2):75-86. doi: 10.1007/s40122-013-0015-x. Epub 2013 Aug 20.
- Background: PubMed 26308433Sigakis MJ, Bittner EA. Ten Myths and Misconceptions Regarding Pain Management in the ICU. Crit Care Med. 2015 Nov;43(11):2468-78. doi: 10.1097/CCM.0000000000001256.
- Background: PubMed 20843604Chanques G, Viel E, Constantin JM, Jung B, de Lattre S, Carr J, Cisse M, Lefrant JY, Jaber S. The measurement of pain in intensive care unit: comparison of 5 self-report intensity scales. Pain. 2010 Dec;151(3):711-721. doi: 10.1016/j.pain.2010.08.039. Epub 2010 Sep 16.
- Background: PubMed 30113379Devlin JW, Skrobik Y, Gelinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299.
- Background: PubMed 16823021Gelinas C, Fillion L, Puntillo KA, Viens C, Fortier M. Validation of the critical-care pain observation tool in adult patients. Am J Crit Care. 2006 Jul;15(4):420-7.
- Background: PubMed 18443635Benyamin R, Trescot AM, Datta S, Buenaventura R, Adlaka R, Sehgal N, Glaser SE, Vallejo R. Opioid complications and side effects. Pain Physician. 2008 Mar;11(2 Suppl):S105-20.
- Background: PubMed 20061837Wibbenmeyer L, Sevier A, Liao J, Williams I, Light T, Latenser B, Lewis R 2nd, Kealey P, Rosenquist R. The impact of opioid administration on resuscitation volumes in thermally injured patients. J Burn Care Res. 2010 Jan-Feb;31(1):48-56. doi: 10.1097/BCR.0b013e3181c7ed30.
- Background: PubMed 27188977Kohler M, Chiu F, Gelber KM, Webb CA, Weyker PD. Pain management in critically ill patients: a review of multimodal treatment options. Pain Manag. 2016 Nov;6(6):591-602. doi: 10.2217/pmt-2016-0002. Epub 2016 May 18.
- Individual participant dataSharing planned: No
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Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
Recruiting
SIRI Levels Following PENG Block in Pediatric Hip Surgery
Hip Dysplasia
Not yet recruitingPhase 2
A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
Pain Management
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammed Gamal Abdelraouf Amer, Pharm D principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nefopam in people with Analgesia and Critical Illness, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative dose of fentanyl (time frame: First 24 hour after randomization.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05071352, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.