PainPhase 4NCT02184273
Efficacy and Tolerability of Nolotil i.v. vs. Placebo i.v. in the Prevention of Postoperative Pain in Children Undergoing Minor Surgery
A Phase 4 study testing Magnesium metamizol in people with Pain, run by Boehringer Ingelheim.
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. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Pain
- What is being tested?
- Magnesium metamizol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- No sites listed yet
- Study dates
- Mar 2002to Mar 2004
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
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- 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
About this study
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 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
- Being tested
- Magnesium metamizol, Placebo
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium metamizolDrug
Also called Nolotil
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Magnesium metamizol | Experimental | Not described Receives: Drug: Magnesium metamizol |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of children requiring rescue medication
Measured: 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
Measured: up to 4 hours
Percentage of children who require rescue medication
Measured: up to 2 hours after drug administration
Evaluation of the pain intensity by the patient by means of a Visual Analogue Scale (VAS)
Measured: up to 4 hours
Evaluation of the pain intensity by the patient by means of a four points Verbal Rating Scale (VRS)
Measured: 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
Measured: up to 4 hours
Assessment of the partial efficacy by the investigator by means of a four points VRS
Measured: up to 4 hours
Assessment of the total efficacy by the investigator by means of a four points VRS
Measured: after 4 hours
Number of patients with adverse events (AE)
Measured: up to 4 hours
Number of withdrawals due to AEs
Measured: up to 4 hours
Assessment of the total tolerability of the assigned treatment by the investigator by means of a four points VRS
Measured: after 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startMar 2002
- Primary completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02184273
- Sponsor's protocol ID
- 1093.18
- Status last verified
- Jul 2014
- First submitted
- 8 Jul 2014
- Last updated
- 10 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02184273
- Acronym / sponsor ID
- 1093.18
- Conditions
- Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Mar 2002
- Primary completion
- Mar 2004 (actual)
- First posted
- 9 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium metamizol | Experimental | Drug: Magnesium metamizol |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium metamizolAlso: Nolotil | Drug | Magnesium metamizol |
| Placebo | Drug | Placebo |
Primary outcome
Percentage of children requiring rescue medication
Time frame: up to 4 hours after drug administration
10 secondary outcomes
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
Assessment of the total tolerability of the assigned treatment by the investigator by means of a four points VRS
Time frame: after 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2014.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Magnesium metamizol in people with Pain, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of children requiring rescue medication (time frame: up to 4 hours after drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2014.