Trial · NCT03918798
The Efficacy and Safety of Chloroprocaine 1% and 2% in Pediatric Population
NCT03918798, Phase 2, Completed, Sintetica SA
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Efficacy and Safety of Chloroprocaine 1% and 2% in Pediatric Population. Trials, record NCT03918798. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03918798
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Efficacy and Safety of Chloroprocaine 1% and 2% in Pediatric Population
- NCT number
- NCT03918798
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 164 participants, actual
- Lead sponsor
- Sintetica SA
- Conditions
- Hernia, Inguinal, Flat Foot
- Interventions
- Chloroprocaine 1% Injectable Solution, Chloroprocaine 2% Injectable Solution
- First posted
- 2019-04-18
- Last updated
- 2026-03-23
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall proportion of patients, in each of the two dosage level groups, not requiring rescue anesthesia during surgery. | Visit 2 (Day 1; surgery/discharge) | The primary efficacy endpoint of the study will be represented by the overall proportion of patients, in each of the two dosage level groups, not requiring rescue anesthesia during surgery. |
| Secondary | Proportion of patients, in both of the two dosage level groups, not requiring rescue anaesthesia (fentanyl) during the two surgical procedures separately | Visit 2 (Day 1; surgery/discharge); FU phone call I( 24 hrs from Visit 2); FU phone call II (7 days from Visit 2) | Proportion of patients, in both of the two dosage level groups, not requiring rescue anaesthesia (fentanyl) during the two surgical procedures separately; Time to onset of sensory block, defined as the time period from completion of the injection (time 0 min) to the achievement of complete sensory block, assessed by pinprick test associated with heart rate measurement, and evaluated for both surgeries; Time to regression of motor block evaluated in 'calcaneo stop' surgery only and assessed by a grade I of the standard Bromage scale (i.e. free movement of legs and feet). Pain intensity evaluated five times in the first 3 hours after patient's awakening andduring the home discharge visit (V2). The technique and appropriate scale for pain measurement are age-dependent therefore, different tools will have to be used for the evaluation: COMFORT scale for patients \<2 months of age; FLACC scale for patients aged \_ 2 months \_ 6 years; Wong-Baker scale for patients over 6 years of age |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03918798
GET https://conductscience.org/api/trials/v1/NCT03918798/registered