This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Emla-Cream as Pain Relief During Pneumococcal Vaccination (NCT01802086), a randomized na study. The primary outcome is Measuring the Effect of Emla Cream on Pain Perception During Pneumococcal Vaccination Measured With Five Items; Face, Legs, Activity, Cry, Consolability (FLACC Scale)..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01802086 |
| Phase | NA |
| Condition | Children, Pain |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 72 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Beatrice Olsson Duse |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns children receiving their first pneumococcal vaccination at the age of three months in child health care. The registry record lists children and pain as the conditions. It does not report further eligibility criteria or a detailed description of the enrolled children.
Intervention
The intervention was Emla cream: 1 g applied for 1 hour, according to the arm description. The primary question concerns whether pain scores around vaccination differed for children assigned to this cream.
Comparator
The comparator was Miniderm cream, described as 1 g applied for 1 hour. The study therefore compared Emla cream with another cream, not with an untreated or no-cream group.
Primary question
The primary endpoint was pain measured with the FLACC scale before vaccination and after vaccination, up to three minutes. The registry question asks whether the Emla group had lower pain scores than the Miniderm group. The registry record does not report group scores, an effect estimate, a confidence interval, or a statistical test answering that question.
In statistical terms, the clinical question is a comparison between randomized groups on a behavioral pain score measured around a procedure. A lower FLACC score represents a better outcome according to the registry description. The record identifies the outcome as a median with an inter-quartile range, which describes the center and spread of scores without relying on a mean and standard deviation. However, the numerical summaries needed to evaluate the group contrast are not reported in the registry record.
3. Trial Design
The registry describes a randomized, single-masked, parallel-group intervention study. The posted enrollment is 72. The arm descriptions list 36 participants at risk in the Emla-cream group and 36 in the Miniderm Cream group. The record marks the study as completed, with a start date of 2013-05 and primary completion date of 2015-11. The sponsor is Beatrice Olsson Duse.
Random allocation is intended, in general, to make treatment groups comparable on average at the start of a study. A parallel design assigns participants to a group and compares outcomes between groups. The registry does not report how the random sequence was generated, how allocation was concealed, or which people were masked. “Single” is the recorded masking designation; the identity of the masked party is not reported in the registry record.
The intervention descriptions specify 1 g of Emla cream for 1 hour and 1 g of Miniderm cream for 1 hour. The comparator matters when interpreting the question: any estimated difference would be a contrast between these two assigned creams under the study conditions, rather than a comparison with no cream. The registry summary frames the study as pain relief versus no pain relief, but the listed comparator arm is Miniderm cream.
The primary outcome was FLACC pain score measured before vaccination and after vaccination, up to three minutes. Secondary outcomes listed are latency time to cry, total crying time, heart rate before and after vaccination, and saturation before and after vaccination. The record lists no registered analyses. It does not report the actual treatment received, adherence, deviations from assignment, withdrawals, or the number contributing data to each outcome. Those details are not reported in the registry record, so the planned randomized comparison cannot be reconstructed from the design description alone.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Emla-cream | Miniderm Cream |
|---|---|---|
| STARTED | 36 | 36 |
| COMPLETED | 36 | 36 |
| NOT COMPLETED | 0 | 0 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Emla-cream | Miniderm Cream | Total |
|---|---|---|---|---|
| Participants analysed | 36 | 36 | 72 | |
| Age, Categorical: <=18 years | Participants | 36 | 36 | 72 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 | 0 | 0 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Sex: Female, Male: Female | Participants | 23 | 17 | 40 |
| Sex: Female, Male: Male | Participants | 13 | 19 | 32 |
6. Primary Endpoint
The registry lists the primary outcome as Measuring the Effect of Emla Cream on Pain Perception During Pneumococcal Vaccination Measured With Five Items; Face, Legs, Activity, Cry, Consolability (FLACC Scale)., measured over Before vaccination and after vaccination, up to three minutes..
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Inter-Quartile Range |
| Unit | score on a scale |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is pain perception assessed with the FLACC behavioral scale. Its name refers to Face, Legs, Activity, Cry, and Consolability. Each item can contribute 0,1 or 2 points according to the scale description, and the total score can range between 0-10 points. Higher scores indicate more pain and therefore a worse outcome.
The registry describes FLACC as a qualitative behavioral pain-assessment scale validated for use in infants aged 2 months to 7 years. A behavioral measure is useful when pain is assessed through observable responses rather than a self-reported rating. The scale organizes observations into specified features, allowing a score to be recorded in a consistent way across assessment occasions. This is the rationale for using it in the stated population; the record does not report how assessors were trained or whether agreement between assessors was evaluated.
The score was assessed before vaccination and after vaccination, up to three minutes, and compared between the Emla-cream and Miniderm-cream groups. The registry identifies the summary measure as a median and the dispersion measure as an inter-quartile range. A median describes the middle of an ordered set of scores; an inter-quartile range describes the spread of the central portion. These summaries can be informative for bounded or non-normally distributed scores, but they do not by themselves establish whether groups differ.
The registry record does not report the observed FLACC values at any assessment time, the change from before to after vaccination, or a group-level contrast. It therefore does not show how much pain was recorded in either group or how precisely any difference was estimated.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a clinically interpretable comparison: FLACC scores in children assigned to Emla cream versus children assigned to Miniderm cream around pneumococcal vaccination. Because higher scores indicate more pain, a lower score in the Emla group would point in the direction specified by the study question. The posted record does not provide the scores or an analysis, however, so the direction and size of the observed group difference cannot be established from the registry information.
No primary-outcome estimate, confidence interval, p-value, or group-specific median and inter-quartile range is reported in the registry record. The analysis count is listed as 0, and the record notes that the primary outcome has several categories or time points and was not reduced to one comparison. Consequently, there is no sponsor-reported primary comparison to interpret and no basis for describing statistical significance or precision.
In general, a confidence interval communicates the range of effects reasonably compatible with the observed data under the analysis assumptions. Its width conveys precision: a narrow interval indicates a more precise estimate than a wide interval. Without an estimate and interval, readers cannot assess whether plausible effects are tightly concentrated or span materially different interpretations. A p-value, if reported, would address compatibility with a specified null model; it would not by itself measure the size or importance of an effect. Neither type of result is reported for this endpoint.
The registry states that the outcome was summarized using a median and inter-quartile range. Those descriptive summaries could characterize score distributions at the stated assessment times, but a comparison still requires a clearly defined contrast and uncertainty estimate. Separate group summaries alone would not necessarily quantify the between-group effect, particularly if measurements before and after vaccination were analyzed together or if the assessment times were handled separately. The intended analysis details are not reported in the registry record.
The record also lists crying time, latency to cry, heart rate, and saturation as secondary outcomes, but it does not report results for them. Their presence in the outcome list does not establish that each was measured successfully or analyzed. The status is completed, but completion status is not a substitute for outcome data.
The registry record therefore supports an account of the research question and design, not a conclusion about the observed effect. It does not establish that Emla cream lowered pain scores, that the groups had similar scores, or that any difference was clinically important. Such interpretations require posted results and an analysis that specifies the comparison, accounts for the repeated assessment timing, and reports uncertainty.
9. Statistical Methods Explained
The record gives a randomized, single-masked, parallel-group design and identifies a median with an inter-quartile range as the summary format for the primary score. It does not report a statistical analysis plan, the method used to generate or conceal allocation, the identity of the masked party, or a model for comparing outcomes. The following statistical explanations are general; they do not describe an analysis confirmed to have been used in this trial.
What does randomization contribute?
In general, random allocation is used to reduce systematic differences in baseline characteristics between groups. It does not guarantee that all characteristics will be identical, especially in a modest study, and it does not prevent differences in care or assessment after allocation. Interpretation still depends on how randomization was implemented, whether participants were analyzed according to assignment, and whether outcome data were available. The registry identifies randomization but does not report implementation details or an analysis population.
What do the median and inter-quartile range describe?
In general, the median is the central ordered observation, while the inter-quartile range describes the middle spread of the observations. These summaries can be suitable for scores that are bounded, discrete, or skewed. FLACC is bounded between 0-10 points, and the record explicitly specifies median and inter-quartile range. Those descriptive statistics do not alone provide a treatment-effect estimate. To compare groups, an analysis must define whether it is comparing scores at a particular time, changes over time, or another summary of the repeated measurements.
A difference between medians is one possible descriptive contrast, but it is not interchangeable with every other measure of group separation. A rank-based analysis, a model for repeated observations, and a comparison of medians answer related but not identical questions. The registry does not report which approach was used, whether an adjusted analysis was planned, or how repeated assessments were handled. No method should be attributed to this trial without a reported analysis.
Why does the assessment timing matter?
The primary measure was taken before vaccination and after vaccination, up to three minutes. Repeated measurements on the same child are generally correlated: observations from one participant tend to share characteristics and are not equivalent to observations from unrelated participants. A suitable analysis needs to account for that dependence if it combines assessment occasions. Alternatively, an analysis could focus on a prespecified occasion or contrast. The registry does not state which approach was selected, and its note that the endpoint has several categories or time points indicates that it was not reduced to a single comparison in the posted record.
Baseline measurement can provide context for post-vaccination scores, but the role of the pre-vaccination measure depends on the analysis. It could be reported descriptively, used for adjustment, or incorporated in a longitudinal model. Those choices affect the estimand and interpretation. The record does not report whether baseline scores were used for adjustment or whether change scores were calculated.
What does uncertainty add?
In general, an effect estimate describes the observed contrast, while an interval estimate communicates uncertainty around it. A statistical test addresses compatibility with a null hypothesis under specified assumptions. Neither an estimate nor a test alone answers whether an effect is important in practice. Interpretation benefits from the outcome scale, the direction of benefit, the effect magnitude, and its uncertainty. The registry record reports none of the numerical results needed for these interpretations.
For medians or other non-normal outcomes, uncertainty estimation can use methods suited to the selected estimand and data structure. The appropriate method depends on the outcome distribution, sample size, repeated-measures structure, and missingness. These are general considerations, not evidence that any particular procedure was used in this study. The statistical plan and uncertainty method are not reported in the registry record.
What is over-dispersion, and is it relevant?
In general, over-dispersion occurs when observed variability is greater than a statistical model expects. It is especially relevant to count outcomes when a model assumes a particular relationship between the mean and variance. Greater variability than expected can make standard errors too small if the model is not adapted, leading to overly precise inference. Crying time and latency to cry are listed as secondary outcomes, but the record does not state their data formats, distributions, or analysis methods. It is therefore not possible to determine whether over-dispersion was assessed or whether it was relevant to the analyses.
What can the planning illustration establish?
In general, sample-size planning asks how much information a future study may need to detect a specified effect under stated assumptions. A planning illustration based on an observed effect is not observed power and is not a substitute for the trial’s analysis. The registry describes an illustration using a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. It specifies participants per arm for non-time-to-event outcomes. No calculated planning values are reported in the registry record, and the record does not say that these assumptions were the study’s original design assumptions.
The record also does not report the original sample-size justification, whether any interim analyses were conducted, or a prespecified statistical analysis plan. These points should remain unknown rather than being inferred from the trial design, the completion status, or the planning description.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome includes assessments before vaccination and after vaccination, up to three minutes. The registry notes that the outcome has several categories or time points and was not reduced to one comparison. It lists secondary outcomes involving crying, heart rate, and saturation, but does not report results or analyses for these outcomes. With multiple outcome measures or assessment times, statistical interpretation can be affected by the number of comparisons and by which results were prespecified. The registry record does not report a multiplicity strategy, a hierarchy of outcomes, or which comparisons were designated as confirmatory.
The analysis count is listed as 0. This means the registry record does not include a registered statistical analysis to interpret; it should not be read as evidence that no analysis was performed outside the registry. Any analysis not documented in the registry record is not reported in the registry record.
Missing-data information is also not reported in the registry record. There are no reported counts of missing FLACC observations at each assessment time, reasons for missingness, or methods for handling incomplete measurements. Without those details, readers cannot assess whether the analyzed observations represent all randomized participants or whether missingness could affect the group comparison.
The record does not identify an intention-to-treat, per-protocol, or other analysis population. It does not describe exclusions after randomization or explain how participants who did not follow their assigned intervention would be handled. These choices can influence the meaning of a treatment comparison. The registry record supports no claim about the completeness of follow-up or the population included in an analysis.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Emla-cream | 0 | 36 | 0.0% |
| Miniderm Cream | 0 | 36 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Emla-cream | 0 of 36 |
| Miniderm Cream | 0 of 36 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Emla-cream | 0 of 36 |
| Miniderm Cream | 0 of 36 |
The safety record lists 36 participants at risk in the Emla-cream arm and 36 in the Miniderm Cream arm. For each arm, the listed count affected by serious adverse events is 0, the count affected by other adverse events is 0, and deaths are 0. These are the counts recorded in the registry; they should be read as reported event counts, not as proof that no adverse event could occur.
In general, a zero recorded count means that no events of that category were reported among the participants included in that safety record. It does not show that the underlying risk is zero. Event counts can be difficult to interpret without knowing how events were defined, how actively they were collected, how long participants were followed, and whether all participants contributed safety information. Those details are not reported in the registry record.
The registry does not provide event descriptions, severity details beyond the serious-versus-other categories, timing, relatedness assessments, or confidence intervals for safety risks. The listed zero counts therefore provide limited descriptive safety information. They do not support a comparative estimate of risk or a broad conclusion about safety.
12. What the Result Does, and Does Not, Mean
The registry record establishes the study question, design, intervention descriptions, outcome definition, and posted adverse-event counts. It describes a randomized comparison of Emla cream with Miniderm cream during pneumococcal vaccination in children aged three months. It also specifies that higher FLACC scores represent more pain and that the intended primary outcome was assessed before vaccination and after vaccination, up to three minutes.
It does not establish what happened to the primary outcome. No group-specific FLACC summaries, between-group estimate, confidence interval, p-value, or statistical analysis is reported in the registry record. Thus, the available record does not show whether pain scores were lower, higher, or similar in the Emla group relative to the Miniderm group. It also does not quantify the precision of any comparison or show whether any observed difference would be important.
The same caution applies to the listed secondary outcomes. Their inclusion in the registry describes outcomes of interest, not results. The safety record reports zero serious adverse events, zero other adverse events, and zero deaths in each arm, but those counts alone cannot establish absence of risk. The registry does not report event definitions, follow-up details, or uncertainty estimates.
In general, a completed study and a registered outcome description do not substitute for an outcome report. A useful interpretation of trial findings requires the observed data, a clearly defined comparison, the analysis method, and information about missing observations and the analysis population. Those elements are not reported in the registry record.
Accordingly, the record supports a description of what the trial set out to compare, but not a conclusion about the comparative effect of the creams. It cannot be used to claim that one cream lowered pain, that there was no difference, or that a difference was clinically meaningful. Those claims would require results and analysis details not reported in the registry record.
13. Why This Trial Matters Statistically
This trial raises several statistical issues that are common in studies of pain during procedures. The primary measure is a behavioral score, recorded around vaccination, with multiple assessment times. Statistical interpretation depends not only on the score’s direction but also on how repeated measurements are combined and how the group contrast is defined.
The FLACC score has a bounded range of 0-10 points and is summarized in the registry by a median and inter-quartile range. This highlights a distinction between describing each group and estimating a comparative effect. Group summaries can describe the observed score distribution, while an effect estimate and its uncertainty are needed to evaluate how the groups differ. The registry record does not report those results.
The comparator is also important. Miniderm cream is an active named comparator in the arm description, even though the brief summary frames the question as Emla cream versus no pain relief. Statistical conclusions must reflect the actual recorded contrast. A result for Emla versus Miniderm would not automatically answer a comparison with no cream.
The record’s note that the primary outcome has multiple categories or time points, together with the absence of a registered analysis, makes prespecification and multiplicity relevant questions. If several times or outcomes are examined, readers need to know which comparison was primary and how the others were interpreted. The record does not provide those details.
Finally, completion status and safety counts are not substitutes for efficacy results. The registry reports the design and event counts but no primary outcome analysis. This makes the distinction between a study’s question and its documented evidence especially clear: the design can be described, while the treatment-effect question remains unanswered by the posted registry record.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The central limitation for interpretation is that the registry record does not report primary-outcome results or a group comparison. It gives no FLACC medians, inter-quartile ranges, effect estimate, confidence interval, or p-value. The record therefore cannot show the direction, magnitude, or precision of the observed pain-score contrast.
The timing and structure of the outcome are described only in broad terms: before vaccination and after vaccination, up to three minutes. The record does not report the exact assessment schedule, how observations were combined, or which time point or contrast was intended to support the primary conclusion. It also does not state whether baseline scores were used in an adjusted analysis.
Although the study is marked randomized and single-masked, allocation procedures and the identity of the masked party are not reported in the registry record. The record also does not report eligibility details, participant characteristics, adherence, protocol deviations, withdrawals, or the analysis population. These omissions limit assessment of how the design was implemented and which participants contributed outcome data.
Missing-data counts and handling methods are not reported. The registry lists several secondary outcomes but supplies no results, no multiplicity strategy, and no analysis plan. As a result, it is not possible to evaluate the intended relationship between the primary and secondary outcomes or to determine how multiple assessment times were addressed.
The safety information is limited to event counts. Definitions, collection methods, follow-up duration, event timing, and uncertainty around the counts are not reported. The registry’s completed status does not resolve these gaps. These are limitations of the registry record and should not be taken as evidence that the study itself did not collect or analyze additional information.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Emla-Cream as Pain Relief During Pneumococcal Vaccination — NCT01802086.
- Registry record last updated 2025-10-23; status last verified 2025-10.
- Results first posted 2025-10-23.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry describes a completed randomized, single-masked, parallel-group study of Emla cream versus Miniderm cream during pneumococcal vaccination in children aged three months. The arm descriptions specify 1 g of cream applied for 1 hour. The posted enrollment is 72, and the safety record lists 36 at risk in each arm.
The primary endpoint is FLACC pain score, assessed before vaccination and after vaccination, up to three minutes. The scale covers Face, Legs, Activity, Cry, and Consolability; higher scores indicate more pain. The registry specifies medians and inter-quartile ranges as the summary format.
No primary outcome results, group comparison, statistical test, or uncertainty estimate are reported in the registry record. Secondary outcomes are listed without results. The safety record lists zero serious adverse events, zero other adverse events, and zero deaths in each arm. The record does not report the analysis population, missing-data handling, multiplicity approach, or detailed statistical plan.