Study to assess the analgesic efficacy in the prevention of postoperative pain in children undergoing minor surgery (herniorraphy, tonsillectomy) and to assess the tolerability of Metamizol in this group of patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
122
Percentage of children requiring rescue medication
Time frame: up to 4 hours after drug administration
Time from drug administration, end of surgery and first patient's awake to the administration of rescue medication
Time frame: up to 4 hours
Percentage of children who require rescue medication
Time frame: up to 2 hours after drug administration
Evaluation of the pain intensity by the patient by means of a Visual Analogue Scale (VAS)
Time frame: up to 4 hours
Evaluation of the pain intensity by the patient by means of a four points Verbal Rating Scale (VRS)
Time frame: up to 4 hours
Assessment of the state of the patient by the guardian by means of the Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) test
Time frame: up to 4 hours
Assessment of the partial efficacy by the investigator by means of a four points VRS
Time frame: up to 4 hours
Assessment of the total efficacy by the investigator by means of a four points VRS
Time frame: after 4 hours
Number of patients with adverse events (AE)
Time frame: up to 4 hours
Number of withdrawals due to AEs
Time frame: up to 4 hours
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Assessment of the total tolerability of the assigned treatment by the investigator by means of a four points VRS
Time frame: after 4 hours