OBJECTIVES: The purpose of this study was to compare the effectiveness of "facilitated tucking by parents" (FTP) in which a parent holds by her hands the infant in a side-lying flexed position offering support and skin contact, oral glucose, opioid (oxycodone), and placebo (oral water) in the context of heel stick and pharyngeal suctioning in very preterm infants. We hypothesized that nonpharmacologic methods equal the pharmacologic method and are superior to placebo in pain management. METHODS: A prospective randomized placebo-controlled crossover trial. The study patients (n=20) were born at a mean gestational age of 28(+1) weeks and were studied at postconceptional age of 28 to 32 weeks. Pain measurements with Premature Infant Pain Profile and Neonatal Infant Pain Scale covered the first 30 seconds after the beginning of the painful stimulus. RESULTS:Premature Infant Pain Profile scores were significantly lower with oral glucose (mean: 4.85+/-1.73, P<or=0.001) and FTP (mean: 5.20+/-1.70, P=0.004) when compared with placebo (mean: 7.05+/-2.16) after heel stick. During pharyngeal suctioning, the scores were lowest with oral glucose (mean: 11.05+/-2.31, P=0.014) and FTP (mean: 11.25+/-2.47, P=0.034) compared with placebo (mean: 12.40+/-2.06). Opioid equaled placebo in both procedures. Neonatal Infant Pain Scale scores were significantly lower with FTP (P<or=0.001) and opioid (P=0.018) after heel stick, and during pharyngeal suctioning with FTP (P=0.001) compared with placebo. We found significantly more short-term adverse effects per administration with oral glucose (21.25%) and oral water (12.5%) compared with opioid (5%) or FTP (5%). DISCUSSION: Our study demonstrated that FTP is not just equal, but preferable to other pain management methods when both efficacy and safety are considered.
RCT Entities:
OBJECTIVES: The purpose of this study was to compare the effectiveness of "facilitated tucking by parents" (FTP) in which a parent holds by her hands the infant in a side-lying flexed position offering support and skin contact, oral glucose, opioid (oxycodone), and placebo (oral water) in the context of heel stick and pharyngeal suctioning in very preterm infants. We hypothesized that nonpharmacologic methods equal the pharmacologic method and are superior to placebo in pain management. METHODS: A prospective randomized placebo-controlled crossover trial. The study patients (n=20) were born at a mean gestational age of 28(+1) weeks and were studied at postconceptional age of 28 to 32 weeks. Pain measurements with Premature InfantPain Profile and Neonatal InfantPain Scale covered the first 30 seconds after the beginning of the painful stimulus. RESULTS: Premature InfantPain Profile scores were significantly lower with oral glucose (mean: 4.85+/-1.73, P<or=0.001) and FTP (mean: 5.20+/-1.70, P=0.004) when compared with placebo (mean: 7.05+/-2.16) after heel stick. During pharyngeal suctioning, the scores were lowest with oral glucose (mean: 11.05+/-2.31, P=0.014) and FTP (mean: 11.25+/-2.47, P=0.034) compared with placebo (mean: 12.40+/-2.06). Opioid equaled placebo in both procedures. Neonatal InfantPain Scale scores were significantly lower with FTP (P<or=0.001) and opioid (P=0.018) after heel stick, and during pharyngeal suctioning with FTP (P=0.001) compared with placebo. We found significantly more short-term adverse effects per administration with oral glucose (21.25%) and oral water (12.5%) compared with opioid (5%) or FTP (5%). DISCUSSION: Our study demonstrated that FTP is not just equal, but preferable to other pain management methods when both efficacy and safety are considered.
Authors: Rebecca R Pillai Riddell; Nicole M Racine; Hannah G Gennis; Kara Turcotte; Lindsay S Uman; Rachel E Horton; Sara Ahola Kohut; Jessica Hillgrove Stuart; Bonnie Stevens; Diana M Lisi Journal: Cochrane Database Syst Rev Date: 2015-12-02