Efficacy and Tolerability of Nolotil i.v. vs. Placebo i.v. in the Prevention of Postoperative Pain in Children Undergoing Minor Surgery
Primary Purpose
Pain
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Magnesium metamizol
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pain
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Magnesium metamizol
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Percentage of children requiring rescue medication
Secondary Outcome Measures
Time from drug administration, end of surgery and first patient's awake to the administration of rescue medication
Percentage of children who require rescue medication
Evaluation of the pain intensity by the patient by means of a Visual Analogue Scale (VAS)
Evaluation of the pain intensity by the patient by means of a four points Verbal Rating Scale (VRS)
Assessment of the state of the patient by the guardian by means of the Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) test
Assessment of the partial efficacy by the investigator by means of a four points VRS
Assessment of the total efficacy by the investigator by means of a four points VRS
Number of patients with adverse events (AE)
Number of withdrawals due to AEs
Assessment of the total tolerability of the assigned treatment by the investigator by means of a four points VRS
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02184273
Brief Title
Efficacy and Tolerability of Nolotil i.v. vs. Placebo i.v. in the Prevention of Postoperative Pain in Children Undergoing Minor Surgery
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
March 2004 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
122 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Magnesium metamizol
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Magnesium metamizol
Other Intervention Name(s)
Nolotil
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Percentage of children requiring rescue medication
Time Frame
up to 4 hours after drug administration
Secondary Outcome Measure Information:
Title
Time from drug administration, end of surgery and first patient's awake to the administration of rescue medication
Time Frame
up to 4 hours
Title
Percentage of children who require rescue medication
Time Frame
up to 2 hours after drug administration
Title
Evaluation of the pain intensity by the patient by means of a Visual Analogue Scale (VAS)
Time Frame
up to 4 hours
Title
Evaluation of the pain intensity by the patient by means of a four points Verbal Rating Scale (VRS)
Time Frame
up to 4 hours
Title
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
Title
Assessment of the partial efficacy by the investigator by means of a four points VRS
Time Frame
up to 4 hours
Title
Assessment of the total efficacy by the investigator by means of a four points VRS
Time Frame
after 4 hours
Title
Number of patients with adverse events (AE)
Time Frame
up to 4 hours
Title
Number of withdrawals due to AEs
Time Frame
up to 4 hours
Title
Assessment of the total tolerability of the assigned treatment by the investigator by means of a four points VRS
Time Frame
after 4 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1093/1093.18_U05-1666.pdf
Description
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Efficacy and Tolerability of Nolotil i.v. vs. Placebo i.v. in the Prevention of Postoperative Pain in Children Undergoing Minor Surgery
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