Banga 2015.
Methods | RCT Painful intervention: each potentially painful procedure for a period of 7 days after enrolment Study location: a tertiary–level teaching hospital in North India Study period: April 2010 to April 2011 |
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Participants | 106 newborns, between completed 32 weeks and 37 weeks PMA were randomized to 2 groups sucrose (n = 53) and water (n = 53). 93 infants were available for analysis (47 in the sucrose group and 46 in the water group) | |
Interventions | Sterile solution 24% sucrose (0.5 mL in 1mL syringe) for every potentially painful procedure during the first 7 days after enrolment Double‐distilled water (0.5 mL in 1mL syringe) for every potentially painful procedure during the first 7 days after enrolment |
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Outcomes | Primary outcome: score of motor development and vigor (MDV) and alertness and orientation (AO) domains of NAPI scale performed at 40 weeks PMA In addition, the highest HR and lowest SpO2 obtained during the procedure were recorded until 30 s after the painful stimulus, for newborns in both groups (not reported) |
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Notes | We wrote to the authors and Dr Banga provided us with this information: The potentially painful procedures included: venipuncture, heel lance, peripheral venous catheterization, OG or NG tube insertion, intramuscular injection, suprapubic bladder tap, retinopathy of prematurity examination, removal of adhesive tapes |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Block randomization using computer‐generated random sequences was used with a static block size of 6 each |
Allocation concealment (selection bias) | Low risk | Allocation sequence was generated and maintained confidentially by the co‐investigator from department of Pharmacology. At the time of enrolment, the group allocation was telephonically conveyed to the research candidate, to ensure allocation concealment |
Blinding (performance bias and detection bias) All outcomes | Low risk | Identical‐looking packets carrying sucrose and the double‐distilled water, prepared and serially labelled according to confidential randomization code by pharmacy, were available at neonatal units. The primary care team members were responsible for administrating the intervention/control to the enrolled newborn according to the allocated serially numbered packet, unaware of the randomization |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The participants, the research candidate, and the primary care team members assessing the painful response were blinded to the group assignment |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 3 infants lost to follow‐up in the sucrose group, intervention discontinued in 1 and 2 died. 5 infants lost to follow1up in the water group and 2 died |
Selective reporting (reporting bias) | Unclear risk | The study protocol was not available to us so we could not judge whether there were any deviations from it |
Other bias | Low risk | Appears free of other bias |