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Comparison of a Comfort Scale and a Numerical Pain Scale on Opioid Consumption After Surgery

Comparison of a Comfort Scale and a Numerical Pain Scale on Opioid Consumption After Surgery: The COMFORT Randomized Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05234216
Acronym
COMFORT
Enrollment
885
Registered
2022-02-10
Start date
2022-05-09
Completion date
2022-07-01
Last updated
2022-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia, Pain Management

Keywords

Comfort scale, Pain scale, numerical verbal scale, postoperative pain

Brief 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. 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.

Interventions

OTHERInformed consent

the investigator will verify the inclusion criteria, the patient's understanding of the protocol and will obtain oral informed consent

PROCEDURESurgery

The patient will undergo surgery in accordance with standard care

BEHAVIORALComfort scale

The patient will be evaluated, in the post-operative care unit, with a comfort scale

BEHAVIORALPain

The patient will be evaluated, in the post-operative care unit, with a pain scale

OTHERQuestionnaires

Evaluation of the Experience of Local/General Anesthesia

Sponsors

Rennes University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Multicenter, prospective, interventional, randomized cluster study.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Opiate consumption in the post-operative care service1 dayOpiate consumption in milligrams in the post-operative care service in morphine equivalent.

Secondary

MeasureTime frameDescription
Opioid consumption in the post-operative care service according to Ambulatory or conventional management1 dayOpioid consumption in mg in the post-operative care service in morphine equivalent according to Ambulatory or conventional management
Opioid consumption in the post-operative care service according to the Risk related to surgery (minor / intermediate / major)1 dayOpioid consumption in mg in the post-operative care service according to the Risk related to surgery (minor / intermediate / major)
Opioid consumption in the post-operative care service according to the Type of surgery1 dayOpioid consumption in mg in the post-operative care service according to the Type of surgery
Determine if the use of a comfort scale in the post-operative care servic is associated with better postoperative analgesia1 dayNumber of postoperative pain episodes (NRS pain \> 3) expressed in the post-operative care servic after extubation, at rest
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) ;1 dayTime from extubation to Kremlin Bicetre score = 0, or modified Aldrete score ≥ 9 or Chung score ≥ 9 (for ambulatory) ;
Determine whether the use of a comfort scale reduces postoperative nausea and vomiting;1 dayNumber of postoperative nausea and vomiting episodes in the post-operative care service, the use of anti-emetic treatment will be assessed ;
Determine whether the use of a comfort scale is associated with improved postoperative satisfaction.1 daySatisfaction questionnaires

Countries

France, Lebanon

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026