Multicentre, Randomized, Clinical Trial in Children With Mild Ankle Sprain: Bandaging vs. no Immobilization

Study Design: A randomized, parallel, open-label, multi-center clinical trial will be conducted at 3 intermediate-complexity hospitals. The study received approval from the center's ethics committee.

Procedure: Every patient presenting with ankle trauma will undergo assessment by the attending physician in the emergency department. The collaborating researchers of the different hospitals will participate in patient enrollment. In cases of grade I or mild sprains, patients and their guardians will be invited to participate in the study after a thorough explanation of the study's purpose and procedures. The severity of the sprain will be assessed using The West Point Ankle Grading System. Adequate analgesia will be ensured during the emergency department consultation.

Upon agreeing to participate in the study and signing the informed consent, randomization and assignment to either the control group or intervention group (receiving a bandage applied by nursing) will take place before the final discharge from the emergency department. The discharge report will specify the standardized treatment based on the assigned group. The attending physician will complete a physical study-specific record and will store the signed informed consent in a designated folder within the pediatric emergency department. The researcher in charge of each center will enter demographic data and variables obtained in the emergency department into a database hosted in the REDcap software. The data of the recruited patients should be entered in the REDcap database at least twice per week. The principal investigator or collaborators will review this REDcap database daily to check the recruited patients and prepare the SMS with the online survey to be sent. A coded patient number and the date of emergency care will be included in a database hosted in the center's electronic repository to determine the timing of follow-up. The SMS will be sent using the SMS sending system of the coordinating hospital of the study.

At 7, 14, and 30 days, the guardians of the patients will receive a SMS with a link that will direct them to the REDcap online survey. In case of no response to the initial attempt, another attempt will be made the following day, and, if no response is received in 48 hours, a telephone call will be made to the patients' guardians. Non-response at 72 hours will be recorded as a loss.

The data from the REDcap electronic database will be periodically reviewed by the principal investigator to monitore data entry and look for possible adverse effect.