Zolnoski 1993.
Methods | RCT Blinding of randomization ‐ yes Blinding of intervention ‐ can't tell Complete follow‐up ‐ yes Blinding of outcome measurement ‐ yes | |
Participants | 20 male NB, 8 ‐ 120 hr age, FT; no maternal medication, BW > 2700 g, 5 min Apgar >/= 7 | |
Interventions | 2.4 ml 24% sucrose (n=10) 2.4 ml water via syringe (n=10) given 3 min prior | |
Outcomes | cry time, HR | |
Notes | ‐ pilot study ‐ Master's thesis ‐ procedure standardized ‐ Gomco clamp | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | A ‐ Adequate |
Participant Characteristics: NB = newborn; AGA = growth appropriate for gestational age; BW = birthweight; FT = full‐term >/= 37 weeks gestation; NICU ‐ neonatal intensive care unit; Interventions: DPNB = dorsal penile nerve block as described in Kirya (1978) using 1% lidocaine without epinephrine; RB = ring block following the procedure outlined by Broadman (1987); local block = local anesthesia performed by injecting 0.4 ml of 1% lidocaine without epinephrine subcutaneously into two positions on the foreskin at the level of the corona; LP cream = a lidocaine‐prilocaine cream commonly known as EMLA (eutectic mixture of local anesthetics); D50W = 50% dextrose oral solution; control/no treatment group = group receiving no intervention for pain; placebo group = group receiving sham intervention which mimics active interventions; WT = the time from completion of administration of pain relief intervention to the start of circumcision procedure; Scales: NIPS = Neonatal Infant Pain Scale consisting of six behavioral components with a composite score of 0 to 7 (Lawrence, 1993); NFCS score = evaluates the presence or absence of 10 discrete facial actions at outlined in Grunau (1987), scored from videotape in 2 sec intervals for the first 20 sec of each circumcision phase; BNAS = Brazelton Neonatal Behavioral Assessment Scale; MDFMCS = Maximally Discriminative Facial Movement Coding System for coding facial movements of three facial regions to determine emotions demonstrated; NCAFS = Nursing Child Assessment Feeding Scale measures mother‐infant interaction using 76 behavioral items grouped into six subscales based on concepts of adaptation and synchronism ‐ mother and infant are observed during natural feeding session; MBPS = modified behavioral pain scale; Physiological measures: HR= heart rate in beats/minute (bpm); TcpO2 = transcutaneous oxygen saturation; O2sat = % oxygen saturation in the blood; BP = blood pressure; RR = respiratory rate in breaths/minute; Biochemical measures: [PC] = plasma cortisol concentration; metHgb = methemoglobin