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

Pain Clinical Trial

Official title:

Randomized, Double Blind, Comparative Trial of the Efficacy and Tolerability of Nolotil i.v. vs. Placebo i.v. in the Prevention of Postoperative Pain in Children of 6 and 11 Years Old Undergoing Minor Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02184273
• Other study ID #: 1093.18
• Status: Completed
• Phase: Phase 4
• First received: July 8, 2014
• Last updated: July 9, 2014
• Start date: March 2002

Study information

• Verified date: July 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. primary completion date: March 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 11 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain
• Pain, Postoperative

Intervention

Drug:
• Magnesium metamizol

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of children requiring rescue medication		up to 4 hours after drug administration	No
Secondary	Time from drug administration, end of surgery and first patient's awake to the administration of rescue medication		up to 4 hours	No
Secondary	Percentage of children who require rescue medication		up to 2 hours after drug administration	No
Secondary	Evaluation of the pain intensity by the patient by means of a Visual Analogue Scale (VAS)		up to 4 hours	No
Secondary	Evaluation of the pain intensity by the patient by means of a four points Verbal Rating Scale (VRS)		up to 4 hours	No
Secondary	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	No
Secondary	Assessment of the partial efficacy by the investigator by means of a four points VRS		up to 4 hours	No
Secondary	Assessment of the total efficacy by the investigator by means of a four points VRS		after 4 hours	No
Secondary	Number of patients with adverse events (AE)		up to 4 hours	No
Secondary	Number of withdrawals due to AEs		up to 4 hours	No
Secondary	Assessment of the total tolerability of the assigned treatment by the investigator by means of a four points VRS		after 4 hours	No

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