Chermont 2009.
| Methods | Randomized controlled trial | |
| Participants | 640 term infants (mean PMA 39 ± 1 weeks, for all groups); 4 groups – standard care, skin‐to‐skin, 25% dextrose, skin‐to‐skin + 25% dextrose Postnatal age, mean ± SD, hrs: 293 ± 13 (skin‐to‐skin care), 29 ± 15 (control), 29 ± 13 (25% dextrose), 27 ± 13 (skin‐to‐skin + 25% dextrose) Birth weight, mean ± SD, g: 3164 ± 371 (intervention); 3163 ± 418 (control); 3252 ± 389 (25% dextrose); 3240 ± 418 (skin‐to‐skin + 25% dextrose) Painful procedure: intramuscular injection Study period: March 2006 to October 2007 |
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| Interventions | Intervention: skin‐to‐skin contact, initiated 2 minutes before injection and persisting throughout procedure Control: standard care during painful procedure Comparison 1: oral 25% dextrose treatment (1 mL), given 2 minutes before injection Comparison 2: combination of oral dextrose treatment and skin‐to‐skin contact strategies Provider: mother provided skin‐to‐skin; oral dextrose provided by nurse or neonatologist |
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| Outcomes | Neonatal Facial Coding System (NFCS) and Neonatal Infant Pain Scale (NIPS) score at baseline, cleansing, injection, and recovery; HR, O₂ saturation | |
| Notes | Country: Brazil Power calculation: yes |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Randomization was performed by using 2 boxes, 1 for male infants and 1 for female infants." |
| Allocation concealment (selection bias) | Unclear risk | "Each box was filled with 320 opaque sealed envelopes, corresponding to 80 envelopes for each analgesic procedure to be performed during immunization." Envelopes should ideally be opaque, sealed and sequentially numbered |
| Blinding (performance bias and detection bias) All outcomes | High risk | "Pain evaluators were aware of skin‐to‐skin contact but were blinded to whether the infant received water or dextrose." |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | "All randomly assigned patients completed the study, with no losses." |
| Selective reporting (reporting bias) | High risk | Data for the primary outcomes (NFCS, NIPS and PIPP scores) were presented in Tables 2 & 3 and Figure 2. The trial registry lists heart rate and oxygen saturation as secondary outcomes. Although these outcomes were covered within the pain scales, no discussion of the results were found |
| Other bias | Unclear risk | The authors failed to report the number of patients assessed for eligibility |