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

Rennes University Hospital

Status: Completed

Conditions: Pain Management; Analgesia

Treatments: Other: Questionnaires; Other: Informed consent; Procedure: Surgery; Behavioral: Comfort scale; Behavioral: Pain

Study type: Interventional

Funder types: Other

Identifiers

NCT05234216

35RC20_8999_COMFORT

2021-A02839-32 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 885 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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885 participants in 2 patient groups

Comfort Group

Experimental group

Description:

Centers evaluating patients after surgery requiring postoperative opioid treatment with an ICU comfort scale.

Treatment:

Procedure: Surgery

Other: Informed consent

Other: Questionnaires

Behavioral: Comfort scale

Pain Group

Other group

Description:

Centers evaluating patients, after surgery requiring postoperative opioid treatment, with a pain numerical verbal scale in the postoperative care service.

Treatment:

Procedure: Surgery

Other: Informed consent

Other: Questionnaires

Behavioral: Pain