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

NCT02184273 | Completed Phase 4

• 1 other identifier: 1093.18
• Study Type: interventional
• Target: 122
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Percentage of children requiring rescue medication

  up to 4 hours after drug administration

Secondary Outcomes (10)

• Time from drug administration, end of surgery and first patient's awake to the administration of rescue medication

  up to 4 hours

• Percentage of children who require rescue medication

  up to 2 hours after drug administration

• Evaluation of the pain intensity by the patient by means of a Visual Analogue Scale (VAS)

  up to 4 hours

• Evaluation of the pain intensity by the patient by means of a four points Verbal Rating Scale (VRS)

  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

  up to 4 hours

Study Arms (2)

Magnesium metamizol

EXPERIMENTAL

Drug: Magnesium metamizol

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Magnesium metamizol DRUG

Also known as: Nolotil

Magnesium metamizol

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Pain

Interventions

metamizole magnesium

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2014
• First Posted: July 9, 2014
• Study Start: March 1, 2002
• Primary Completion: March 1, 2004
• Last Updated: July 10, 2014

Record last verified: 2014-07