| Study characteristics |
| Methods |
Randomized, double‐blind, controlled trial |
| Participants |
54 preterm infants ≤ 32 gestational age needing PICC during their first 2 weeks of life were eligible for the study.
Exclusion criteria: major congenital anomalies, perinatal asphyxia, severe intracerebral hemorrhage, neurological disorders, sepsis, or concomitant infusion of other opioids, sedatives, or neuromuscular blockers.
Remifentanil group (n = 27; mean GA 28 SD 2 weeks; BW 1108 SD 371 g)
5% dextrose (placebo) group (n = 27; mean GA 29 SD 2 weeks; BW 1144 SD 307 g) |
| Interventions |
Remifentanil group: 0.03 μg/kg/min continuous infusion (intravenously)
5% dextrose (placebo) continuous infusion (intravenously) |
| Outcomes |
NIPS and PIPP (scored before procedure, during skin preparation, needle insertion, and recovery phase lasting 15 min after completing the maneuver), changes in oxygen demand, RR, HR, SaO², blood pressure, body movements |
| Funding sources |
Not reported |
| Declaration of interest among the primary researchers |
Not reported |
| Notes |
Quote: "All enrolled infants also received 0.3 ml of a 12% sucrose solution (0.036 g) per os and non‐nutritive sucking 2 min before the procedure" |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Quote: "The infants were randomized sequentially, using a random numbers table" |
| Allocation concealment (selection bias) |
Low risk |
Quote: "A single pharmacist responsible for allocating each neonate to the randomized treatment group also ensured that the two preparations were indistinguishable" |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Quote: "A single pharmacist responsible for allocating each neonate to the randomized treatment group also ensured that the two preparations were indistinguishable" |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Quote: "a digital camera and the PIPP and NIPS scores were awarded independently and blindly by two researchers unaware of which infants received the treatment" |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Outcomes are reported for all randomized infants—see Trial profile. |
| Selective reporting (reporting bias) |
Unclear risk |
No protocol available. |
| Other bias |
Low risk |
None |
