Kaur 2003.
| Methods | Single‐centre randomised controlled trial performed in India. | |
| Participants | 60 newborn infants ≥ 34 weeks' gestation, postnatal age < 4 weeks and undergoing diagnostic lumbar puncture. Uncomplicated vaginal or caesarean section delivery, 5‐minute Apgar score ≥ 7, no history of maternal medication use, absence of structural neurodevelopmental anomalies and a rectal temperature of 37 ± 0.5 °C. Lumbar puncture was performed to rule out meningitis in ill newborns with seizures or sepsis, according to intensive care treatment protocol. Exclusion criteria: infants receiving sedatives or analgesics. |
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| Interventions | Intervention: EMLA 1.0 g cream. Placebo: 1.0 g cream. Both creams were applied to 1 cm2 of skin under an occlusive dressing for 60 to 90 minutes, then wiped off and the lumbar puncture procedure performed immediately. |
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| Outcomes | Pain using NFCS score: 4 items of facial action (brow bulge, eye squeeze, nasolabial furrow and open mouth) and the presence of crying used as measures of behavioural response to pain. Each response given a score of 1 if present and 0 if absent, for a possible total ranging from 0 to 5. Heart rate. Oxygen saturation. Methaemoglobinaemia (clinical symptoms). Adverse effects. |
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| Notes | Power calculation performed: 21 infants per group were needed. Kaur (2003) used 1 total NFCS score of 0 to 5, where presence of a behaviour score = 1 point and absence = 0 points for each of the 5 variables. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated simple random number table. |
| Allocation concealment (selection bias) | Low risk | Neonates received either EMLA or the placebo cream "in a double‐blind manner". |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Placebo cream consisted of an inert oil that resembled EMLA. EMLA and placebo were supplied in identical tubes marked only with a number. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information provided. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Outcomes for all infants reported. |
| Selective reporting (reporting bias) | Unclear risk | Protocol not obtained. |
| Other bias | Low risk | |