| Study characteristics |
| Methods |
Open‐label parallel randomized clinical trial |
| Participants |
58 spontaneously breathing preterm infants undergoing laser for ROP
Exclusion criteria: neonates with gross congenital malformations, on anticonvulsants/sedatives prior to the procedure, and cholestasis.
Fentanyl group (n = 29; mean GA 30.3 SD 2.2 weeks; mean BW 1347 SD 291 g)
Sucrose group (n = 29; mean GA 30.3 SD 2.4 weeks; mean BW 1321 SD 275 g) |
| Interventions |
Fentanyl infusion: 1 μg/kg/hour, infusion started 15 min prior to the procedure, and the infusion was continued till the procedure was over
Sucrose group 24% single dose, infusion started 15 min prior to the procedure, and the infusion was continued till the procedure was over |
| Outcomes |
Proportion of time spent crying, salivary cortisol levels before, immediately after, and 12 to 24 hours after procedure, PIPP‐R score every 10 min during the procedure, proportion of infants requiring mechanical ventilation in the first 24 hours postprocedure, proportion of infants having feeding intolerance and urinary retention in the first 24 hours postprocedure |
| Funding sources |
Not reported |
| Declaration of interest among the primary researchers |
The authors declare that they have no conflicts of interest. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Quote: "We used computer generated random numbers with variable block size (2 to 8) to allocate the neonates into the two groups" |
| Allocation concealment (selection bias) |
Low risk |
Quote: "An investigator, who did not participate in collecting baseline data, applying the intervention or measurement of outcomes, prepared the randomization sequence. To ensure allocation concealment, random treatment assignment was placed in serially numbered opaque and sealed envelopes" |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Unblinded |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Quote: "However, the outcome assessor was blinded to the group assignment" |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Outcomes are reported for all randomized infants—see Fig 2 Trial flow. |
| Selective reporting (reporting bias) |
Low risk |
Quote: "This trial was registered with Central Trial Registry‐India with registration no. CTRI/2017/07/008977" |
| Other bias |
Low risk |
None |
