Trial · NCT00267111
Topical Amethocaine Gel for Intramuscular Injection in Term Neonates
NCT00267111, Phase 2, Completed, Mount Sinai Hospital, Canada; results first posted 2012-04-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Topical Amethocaine Gel for Intramuscular Injection in Term Neonates. Trials, record NCT00267111. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00267111
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Topical Amethocaine Gel for Intramuscular Injection in Term Neonates
- NCT number
- NCT00267111
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 110 participants, actual
- Lead sponsor
- Mount Sinai Hospital, Canada
- Conditions
- Pain
- Interventions
- Eucerin plus, Amethocaine gel 4%
- First posted
- 2005-12-20
- Last updated
- 2024-07-30
- Results first posted
- 2012-04-23
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pain Scores Assessed by Neonatal Facial Action | For the purpose of analysis IM injection procedure was divided into 4 phases: baseline , cleansing, injection and recovery phases.. For each phase facial actions were scored for the first 20 seconds or less if the phase lasted < 20 seconds. | The presence or absence of 3 facial actions (brow bulge, eyes squeeze and deepening of the nasolabial furrow) were scored in 2 second intervals for the first 20 seconds (or less if the phase lasted \< 20 seconds) of each procedure phase from the videotapes by a trained research assistant. The data were then collapsed for each facial action into the percentage of time the infant expressed the action. An overall pain score was computed by summing the percentage scores for the three facial actions and then dividing by three. The score ranged from 0% to 100% with higher values suggesting more pain. |
| Secondary | Visual Analogue Scale | During the entire procedure | Parents and nurses were asked to assess the infant's pain response during the procedure using Visual analogue scale (VAS) on an unmarked horizontal 10 cm continuous line where 0="no pain" on the left side and 10="worst possible pain" on the right side. Parents and nurses were trained to use the VAS prior to the IM injection. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pain Scores Assessed by Neonatal Facial Action | For the purpose of analysis IM injection procedure was divided into 4 phases: baseline , cleansing, injection and recovery phases.. For each phase facial actions were scored for the first 20 seconds or less if the phase lasted < 20 seconds. | Intention to treat analysis | Percentage of time | MEAN |
| SECONDARY | Visual Analogue Scale | During the entire procedure | Intention to treat analysis | Cms | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pain Scores Assessed by Neonatal Facial Action | 1 g Amethocaine Gel 4% | Baseline | 14 | Standard Deviation 26 | Percentage of time |
| Pain Scores Assessed by Neonatal Facial Action | Placebo Group | Baseline | 18 | Standard Deviation 28 | Percentage of time |
| Pain Scores Assessed by Neonatal Facial Action | 1 g Amethocaine Gel 4% | Cleaning | 30 | Standard Deviation 39 | Percentage of time |
| Pain Scores Assessed by Neonatal Facial Action | Placebo Group | Cleaning | 44 | Standard Deviation 42 | Percentage of time |
| Pain Scores Assessed by Neonatal Facial Action | 1 g Amethocaine Gel 4% | Injection | 70 | Standard Deviation 32 | Percentage of time |
| Pain Scores Assessed by Neonatal Facial Action | Placebo Group | Injection | 75 | Standard Deviation 34 | Percentage of time |
| Pain Scores Assessed by Neonatal Facial Action | 1 g Amethocaine Gel 4% | Recovery | 79 | Standard Deviation 24 | Percentage of time |
| Pain Scores Assessed by Neonatal Facial Action | Placebo Group | Recovery | 76 | Standard Deviation 28 | Percentage of time |
| Visual Analogue Scale | Amethocaine Gel 4% Group | Parents VAS rating | 4.6 | Standard Deviation 2.3 | Cms |
| Visual Analogue Scale | Placebo Group | Parents VAS rating | 4.6 | Standard Deviation 2.4 | Cms |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Amethocaine Gel 4% Group | 55 | |
| Overall Study | STARTED | Placebo Group | 55 | |
| Overall Study | COMPLETED | Amethocaine Gel 4% Group | 55 | |
| Overall Study | COMPLETED | Placebo Group | 55 | |
| Overall Study | NOT COMPLETED | Amethocaine Gel 4% Group | 0 | |
| Overall Study | NOT COMPLETED | Placebo Group | 0 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Local erythema | Skin and subcutaneous tissue disorders | Amethocaine Gel 4% Group | 7 | 54 | 54 |
| other | Local erythema | Skin and subcutaneous tissue disorders | Placebo Group | 4 | 53 | 53 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Amethocaine Gel 4% Group | ||
| Total, all-cause mortality | Placebo Group | ||
| Total, other adverse events | Amethocaine Gel 4% Group | 7 | 54 |
| Total, other adverse events | Placebo Group | 4 | 53 |
| Total, serious adverse events | Amethocaine Gel 4% Group | 0 | 54 |
| Total, serious adverse events | Placebo Group | 0 | 53 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 18343253 | RESULT |
Source PubMed
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Amethocaine Gel 4% Group vs Placebo Group: serious adverse events |
Source Trial comparisons
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/NCT00267111
GET https://conductscience.org/api/trials/v1/NCT00267111/registered