Efficacy and Tolerability of Nolotil i.v. vs. Placebo i.v. in the Prevention of Postoperative Pain in Children Undergoing Minor Surgery

Boehringer Ingelheim

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Drug: Placebo; Drug: Magnesium metamizol

Study type: Interventional

Funder types: Industry

Identifiers

NCT02184273

1093.18

Details and patient eligibility

About

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.

Enrollment: 122 patients

Sex: All

Ages: 6 to 11 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children of either sex between 6 and 11 years of age
• Patients undergoing routine inguinal hernia repair or tonsillectomy
• Written informed consents by the guardian, according to the guidelines of Good Clinical Practice and current legislation
• The ability of the patient to understand and carry out the visual analogue scale assessments
• Patients with a physical status American Society of Anesthesiologist I or II class

Exclusion criteria

• The use of any drug with analgesic properties in the 24 hours prior to the administration of the study drug
• Surgery with a foreseen duration over 60 minutes
• Patients with a nutritional index of less than 90 or greater than 120
• Patients with a body mass index which was not between the 3rd centile and the 97th centile for age
• Patients with any illness or malformation (except hernia) which, in the doctor's opinion, contraindicated the use of metamizol (aplastic anemia, agranulocytosis of a toxicological etiology, severe renal disease, etc.)
• Patients who have received in the previous 7 days or need currently anticoagulant treatment
• Significant allergy or known hypersensitivity to metamizol, its excipients and/or to other nonsteroidal antiinflammatory drugs
• Patients in whom the anesthetic regimen required by the protocol cannot be used
• Patients who have participated in another clinical trial in the past four weeks or are currently participating in another clinical trial
• Patients with any psychological disturbance which, in the investigator's opinion makes the patient unsuitable for inclusion in the trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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122 participants in 2 patient groups, including a placebo group

Magnesium metamizol

Experimental group

Treatment:

Drug: Magnesium metamizol

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo