Bonetto 2008.
| Methods | Randomised controlled trial performed in Argentina. | |
| Participants | Healthy newborn infants at term requiring heel lancing. Inclusion criteria: gestation ≥ 36 weeks; > 24 hours' postnatal age to < 30 days of life. Exclusion criteria: allergies related to medications, treatment with oxygen, treatment for infection, analgesics or sedatives before procedure, skin infection or disorder. |
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| Interventions | Placebo: 1. via oral drops; 2. via oral syringe; 3. via cream on skin. Glucose (given via oral syringe) vs 1. placebo via oral drops; 2. placebo cream on skin. Paracetamol (given orally using a syringe) vs 1. placebo via oral drops; 2. placebo via oral syringe. EMLA cream on skin vs 1. placebo via oral drops 2. placebo via oral syringe. No non‐nutritive sucking or any other nourishment. EMLA and placebo cream left on the skin for 60 minutes then removed with a dry cloth and after a further 10 minutes of procedure attended. |
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| Outcomes | Pain: measured at insertion of heel lance up to 3 minutes using the 0 to 18 PIPP score for infants > 36 weeks' gestation. PIPP scale: a PIPP score < 8 indicated absence or minimal pain; a PIPP score > 8 indicated moderate pain. NIPS scale: a NIPS score of 0 indicated no pain, and a maximum score of 7 indicated moderate‐to‐severe pain. |
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| Notes | Study translated from Spanish to English via interpreter. Power calculation not reported. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation. |
| Allocation concealment (selection bias) | Low risk | Computer‐generated randomisation. |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Hydrating cream identical to EMLA; blinding of treating doctor, doctor who performed blood extraction and parents. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Pain measurement performed by 2 observers who were blinded. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All outcome data reported. |
| Selective reporting (reporting bias) | Unclear risk | Protocol not obtained. |
| Other bias | Low risk | |