Pain ManagementCOMFORTNCT05234216
Comparison of a Comfort Scale and a Numerical Pain Scale on Opioid Consumption After Surgery
A study testing Informed consent, Surgery and Comfort scale in people with Pain Management and Analgesia, run by Rennes University Hospital at 29 sites in 2 countries.
Trial summary
The objective is to show that the use of therapeutic communication tools, in this case a comfort scale, a low cost and simple to implement method, can reduce pain and therefore the consumption of opioids in the postoperative care unit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain Management, Analgesia
- What is being tested?
- Informed consent, Surgery and Comfort scale
- Type of treatment
- Pill or oral medicine, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 885 participants
- Where
- 29 sitesin 2 countries
- Study dates
- 9 May 2022to 1 Jul 2022
- Phase
- Interventional
- 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
- Age ≥ 18 years;
- Patient eligible for any surgery requiring postoperative opioid administration;
- Patient with a social security plan;
- French-speaking patient
- Free, informed and oral consent by the patient.
Who cannot join
- Woman claiming to be pregnant or breast feeding;
- Emergency surgery;
- Patients using preoperative opioids ;
- Opioid addiction;
- Patients unable to understand the assessment scales;
- Adults under legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty.
Trial locations and contacts
29 sites in 2 countries.
29 sites in 2 countries
France28 sites
CHRU Amiens Picardie
Amiens
CHU Angers
Angers
CH Bourg en Bresse
Bourg-en-Bresse
CH Pierre Oudot
Bourgoin
HIA Clermont Tonnerre
Brest
Hôpital Privé Sévigné
Cesson-Sévigné
CH Sud Francilien
Corbeil-Essonnes
CH Dax
Dax
GHM de Grenoble
Grenoble
CH La Rochelle
La Rochelle
CHRU Lille - Hôpital Huriez
Lille
CH Saint Joseph Saint Luc
Lyon
Clinique du Parc
Lyon
Clinique Juge
Marseille
Clinique Jules Verne
Nantes
APHP - Hôpital Bichat
Paris
APHP - Hôpital Cochin
Paris
Chu Rennes - Pontchaillou
Rennes, CHU de Rennes, 35033
Polyclinique Saint Laurent de Rennes
Rennes
CH Saint-Brieuc
Saint-Brieuc
Centre Hospitalier Privé St Grégoire
Saint-Grégoire
Clinique Saint-Jean Cap Santé
Saint-Jean-de-Védas
CHRU Strasbourg - Hôpital Hautepierre
Strasbourg
Hôpital Foch
Suresnes
CHU Toulouse - Hôpital Rangueil
Toulouse
CHU Toulouse - Hôpital Riquet
Toulouse
CHRU Tours - Hôpital Bretonneau
Tours
CH Bretagne Atlantique
Vannes
About this study
Official title: Comparison of a Comfort Scale and a Numerical Pain Scale on Opioid Consumption After Surgery: The COMFORT Randomized Trial
The objective is to show that the use of therapeutic communication tools, in this case a comfort scale, a low cost and simple to implement method, can reduce pain and therefore the consumption of opioids in the postoperative care unit.
Our hypothesis is that the use of a comfort scale will lead to significant postoperative opioid sparing, and consequently to a decrease in the opioid-related side effects The aim of this study is to compare postoperative opioid consumption between patients whose pain is assessed by a numerical verbal scale and those assessed with a comfort scale.
- Conditions
- Pain Management, Analgesia
- Being tested
- Informed consent, Surgery, Comfort scale, Pain, Questionnaires
- Keywords
- Comfort scale, Pain scale, numerical verbal scale, postoperative pain
- Medical subject headings
- Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Informed consentOther
the investigator will verify the inclusion criteria, the patient's understanding of the protocol and will obtain oral informed consent
SurgeryProcedure or surgery
The patient will undergo surgery in accordance with standard care
Comfort scaleBehavioural
The patient will be evaluated, in the post-operative care unit, with a comfort scale
PainBehavioural
The patient will be evaluated, in the post-operative care unit, with a pain scale
QuestionnairesOther
Evaluation of the Experience of Local/General Anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Comfort Group | Experimental | Centers evaluating patients after surgery requiring postoperative opioid treatment with an ICU comfort scale. Receives: Other: Informed consent; Procedure: Surgery; Behavioral: Comfort scale; Other: Questionnaires |
| Pain Group | Other | Centers evaluating patients, after surgery requiring postoperative opioid treatment, with a pain numerical verbal scale in the postoperative care service. Receives: Other: Informed consent; Procedure: Surgery; Behavioral: Pain; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opiate consumption in the post-operative care service
Opiate consumption in milligrams in the post-operative care service in morphine equivalent.
Measured: 1 day
Secondary outcomes (7)
Opioid consumption in the post-operative care service according to Ambulatory or conventional management
Opioid consumption in mg in the post-operative care service in morphine equivalent according to Ambulatory or conventional management
Measured: 1 day
Opioid consumption in the post-operative care service according to the Risk related to surgery (minor / intermediate / major)
Opioid consumption in mg in the post-operative care service according to the Risk related to surgery (minor / intermediate / major)
Measured: 1 day
Opioid consumption in the post-operative care service according to the Type of surgery
Opioid consumption in mg in the post-operative care service according to the Type of surgery
Measured: 1 day
Determine if the use of a comfort scale in the post-operative care servic is associated with better postoperative analgesia
Number of postoperative pain episodes (NRS pain > 3) expressed in the post-operative care servic after extubation, at rest
Measured: 1 day
Determine if the use of a comfort scale can reduce the time to achieve a Kremlin Bicetre score = 0, or a modified Aldrete score ≥ 9 or a Chung score ≥ 9 (for ambulatory) ;
Time from extubation to Kremlin Bicetre score = 0, or modified Aldrete score ≥ 9 or Chung score ≥ 9 (for ambulatory) ;
Measured: 1 day
Determine whether the use of a comfort scale reduces postoperative nausea and vomiting;
Number of postoperative nausea and vomiting episodes in the post-operative care service, the use of anti-emetic treatment will be assessed ;
Measured: 1 day
Determine whether the use of a comfort scale is associated with improved postoperative satisfaction.
Satisfaction questionnaires
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start9 May 2022
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, prospective, interventional, randomized cluster study.
- Masking
- None (open label)
- Enrolment
- 885 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ludovic MEURET, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05234216
- Sponsor's protocol ID
- 35RC20_8999_COMFORT
- Other IDs
- 2021-A02839-32
- Acronym
- COMFORT
- Status last verified
- Oct 2026
- First submitted
- 1 Feb 2022
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fusco N, Meuret L, Bernard F, Musellec H, Martin L, Leonard M, Lasocki S, Gazeau T, Aubertin R, Blayac D, Leviel F, Danguy des Deserts M, Madi-Jebara S, Fessler J, Lecoeur S, Cirenei C, Menut R, Lebreton C, Bouvier S, Bonnet C, Maurice-Szamburski A, Cattenoz M, El Alami M, Brocas E, Aveline C, Gueguen L, Noll E, Gouel-Cheron A, Evrard O, Fontaine M, Nguyen YL, Ravry C, Boselli E, Laviolle B, Beloeil H; COMFORT Study Group and the French Society of Anesthesiologists (SFAR) Research Network. Effect of a comfort scale compared with a pain numerical rate scale on opioids consumption in postanaesthesia care unit: the COMFORT study. Br J Anaesth. 2024 Oct;133(4):839-845. doi: 10.1016/j.bja.2024.06.029. Epub 2024 Sep 7.
PubMed 39244480
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a Comfort Scale and a Numerical Pain Scale on Opioid Consumption After Surgery: The COMFORT Randomized Trial
- ClinicalTrials.gov ID
- NCT05234216
- Acronym / sponsor ID
- COMFORT / 35RC20_8999_COMFORT
- Conditions
- Pain Management, Analgesia
- Keywords
- Comfort scale, Pain scale, numerical verbal scale, postoperative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 885 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 9 May 2022 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 10 Feb 2022 (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 objective is to show that the use of therapeutic communication tools, in this case a comfort scale, a low cost and simple to implement method, can reduce pain and therefore the consumption of opioids in the postoperative care unit.
Our hypothesis is that the use of a comfort scale will lead to significant postoperative opioid sparing, and consequently to a decrease in the opioid-related side effects The aim of this study is to compare postoperative opioid consumption between patients whose pain is assessed by a numerical verbal scale and those assessed with a comfort scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter, prospective, interventional, randomized cluster study.
| Arm | Type | Receives |
|---|---|---|
| Comfort Group | Experimental | Other: Informed consent, Procedure: Surgery, Behavioral: Comfort scale, Other: QuestionnairesCenters evaluating patients after surgery requiring postoperative opioid treatment with an ICU comfort scale. |
| Pain Group | Other | Other: Informed consent, Procedure: Surgery, Behavioral: Pain, Other: QuestionnairesCenters evaluating patients, after surgery requiring postoperative opioid treatment, with a pain numerical verbal scale in the postoperative care service. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years;
- Patient eligible for any surgery requiring postoperative opioid administration;
- Patient with a social security plan;
- French-speaking patient
- Free, informed and oral consent by the patient.
Key exclusion criteria (6 listed)
- Woman claiming to be pregnant or breast feeding;
- Emergency surgery;
- Patients using preoperative opioids ;
- Opioid addiction;
- Patients unable to understand the assessment scales;
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 |
|---|---|---|
| Informed consentthe investigator will verify the inclusion criteria, the patient's understanding of the protocol and will obtain oral informed consent | Other | Comfort Group, Pain Group |
| SurgeryThe patient will undergo surgery in accordance with standard care | Procedure or surgery | Comfort Group, Pain Group |
| Comfort scaleThe patient will be evaluated, in the post-operative care unit, with a comfort scale | Behavioural | Comfort Group |
| PainThe patient will be evaluated, in the post-operative care unit, with a pain scale | Behavioural | Pain Group |
| QuestionnairesEvaluation of the Experience of Local/General Anesthesia | Other | Comfort Group, Pain Group |
Primary outcome
Opiate consumption in the post-operative care service
Time frame: 1 day
Opiate consumption in milligrams in the post-operative care service in morphine equivalent.
7 secondary outcomes
Opioid consumption in the post-operative care service according to Ambulatory or conventional management
Time frame: 1 day
Opioid consumption in the post-operative care service according to the Risk related to surgery (minor / intermediate / major)
Time frame: 1 day
Opioid consumption in the post-operative care service according to the Type of surgery
Time frame: 1 day
Determine if the use of a comfort scale in the post-operative care servic is associated with better postoperative analgesia
Time frame: 1 day
Determine if the use of a comfort scale can reduce the time to achieve a Kremlin Bicetre score = 0, or a modified Aldrete score ≥ 9 or a Chung score ≥ 9 (for ambulatory) ;
Time frame: 1 day
Determine whether the use of a comfort scale reduces postoperative nausea and vomiting;
Time frame: 1 day
Determine whether the use of a comfort scale is associated with improved postoperative satisfaction.
Time frame: 1 day
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 Oct 2026.
- Results publication: PubMed 39244480Fusco N, Meuret L, Bernard F, Musellec H, Martin L, Leonard M, Lasocki S, Gazeau T, Aubertin R, Blayac D, Leviel F, Danguy des Deserts M, Madi-Jebara S, Fessler J, Lecoeur S, Cirenei C, Menut R, Lebreton C, Bouvier S, Bonnet C, Maurice-Szamburski A, Cattenoz M, El Alami M, Brocas E, Aveline C, Gueguen L, Noll E, Gouel-Cheron A, Evrard O, Fontaine M, Nguyen YL, Ravry C, Boselli E, Laviolle B, Beloeil H; COMFORT Study Group and the French Society of Anesthesiologists (SFAR) Research Network. Effect of a comfort scale compared with a pain numerical rate scale on opioids consumption in postanaesthesia care unit: the COMFORT study. Br J Anaesth. 2024 Oct;133(4):839-845. doi: 10.1016/j.bja.2024.06.029. Epub 2024 Sep 7.
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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.
Ludovic MEURET principal investigator
Rennes University Hospital
29 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Informed consent, Surgery and Comfort scale in people with Pain Management and Analgesia, run by Rennes University Hospital at 29 sites in 2 countries.
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 5 inclusion and 6 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 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in France, Lebanon. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Opiate consumption in the post-operative care service (time frame: 1 day). 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 NCT05234216, which also lists 1 linked publication.
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 Oct 2026.