| Study characteristics |
| Methods |
Randomized controlled trial |
| Participants |
29 infants whose birthweight ranged from 600 to 1350 g
No inclusion and exclusion criteria defined.
Fentanyl group (n = 15; mean GA 28 SD 2 weeks; mean BW 953 SD 205 g)
Secobarbital group (n = 14; mean GA 27 SD 2 weeks; mean BW 931 SD 209 g) |
| Interventions |
Fentanyl group: 2 μg/kg single dose (intravenously)
Secobarbital group: 1 mg/kg single dose (intravenously) |
| Outcomes |
Heart rate, oxygen saturation, blood pressure, blood glucose, plasma catecholamines, duration of procedure |
| Funding sources |
Not reported |
| Declaration of interest among the primary researchers |
Not reported |
| Notes |
Quote: "Local anesthesia was accomplished by infiltrating 5 mg/kg of lidocaine 1% subcutaneously in three to four divided doses" |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Quote: "After informed consent was obtained from the parents, infants were randomly assigned to receive either fentanyl 2 µg/kg or secobarbital 1 mg/kg intravenously." |
| Allocation concealment (selection bias) |
Unclear risk |
Not reported |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Not reported |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Not reported, but outcomes were all lab or monitor values (objective) |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Outcomes are reported for all randomized infants—see Table 1. |
| Selective reporting (reporting bias) |
Unclear risk |
No protocol available. |
| Other bias |
Low risk |
None |
