152: A Randomized Double-Blind Trial on the Effect on Pain of an Oral Sucrose Solution in Children 1 to 3 Months Old Undergoing Simple Venipuncture
Bibliographic record
Abstract
The evidence of the analgesic effect of oral sweet solutions has been established in neonates. However, there have been a limited number of published clinical trials in older infants. To compare the efficacy of an oral sucrose solution versus placebo in reducing pain in children 1 to 3 months of age undergoing venipuncture without cannulation in the Emergency Department (ED). A single-center, randomized, double-blind, placebo controlled clinical trial was conducted in a pediatric university-affiliated hospital ED. Infants 1 to 3 months of age requiring venipuncture were recruited. Participants were randomly allocated to receive 2 mL of 88% sucrose solution or 2 mL of a placebo solution orally, two minutes before the procedure. The primary outcome measure was the difference in pain levels during venipuncture as assessed by the Face, Legs, Activity, Cry and Consolability Pain Scale (FLACC) one minute post venipuncture vs baseline. Secondary outcome measures were the difference in pain levels using the Neonatal Infant Pain Scale (NIPS) one minute post venipuncture, crying time and variations in heart rate following the procedure. Eighty-two participants were recruited, 41 in the sucrose group and 41 in the placebo group. Both groups had similar baseline demographic and clinical characteristics, including administration of pacifier and other analgesia. The mean difference in FLACC pain scores compared to baseline was 3.67±0.62 in the placebo group vs 3.51±0.64 in the sucrose group (P=0.73). For the NIPS pain score, it was 3.00±0.49 (placebo) vs 2.90±0.47 (sucrose) (P=0.89). The difference in the mean crying time following venipuncture was not statistically significant between both groups: 96±8 seconds (placebo) vs 66±5 (sucrose) (P=0.32). No significant difference was found in the difference of participants' heart rates one minute post venipuncture compared to baseline: 24±5 beats per minute (placebo) vs 33±6 (sucrose) (P=0.44). No significant adverse effects were reported. The overall blinding was successful. In children 1 to 3 months of age undergoing simple venipuncture in the ED, administration of an oral sweet solution did not statistically decrease pain scores as measured by the FLACC and NIPS scales. The participants' heart rate variations and crying time were not significantly changed by providing sucrose instead of a placebo.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.005 | 0.002 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.003 | 0.002 |
| Insufficient payload (model declined to judge) | 0.009 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".