Serge Gouin1, Laurence Alix-Séguin1, Marie Pier Desjardins1, Jocelyn Gravel1, Denis Lebel2, Nathalie Gaucher1. 1. Departments of Pediatric Emergency Medicine & Pediatrics, Centre Hospitalier Universitaire Sainte-Justine, Université de Montréal, Montreal, Quebec, Canada. 2. Department of Pharmacy, Centre Hospitalier Universitaire Sainte-Justine, Université de Montréal, Montreal, Quebec, Canada.
Abstract
BACKGROUND:Oral sweet solutions have been proposed as effective pain-reducing agents for procedures. OBJECTIVES: To compare the efficacy of an oral sucrose solution vs. placebo in alleviating pain in children (1-3 months) during nasopharyngeal aspiration (NPA). METHODS: A randomized, double-blind, controlled clinical trial was conducted in a pediatric hospital emergency department. Participants (aged 1-3 months) requiring NPA were randomly allocated to receive 2 mL of 88% sucrose (SUC) or 2 mL of a placebo (PLA) 2 min prior to the procedure. The primary outcome was the mean difference in pain scores at 1 min post NPA as assessed by the Face, Legs, Activity, Cry and Consolability (FLACC) Pain Scale. RESULTS:Seventy-two participants completed the study, 37 receiving SUC and 35 PLA. The mean difference in FLACC scores compared with baseline was 3.3 (2.5-4.1) for SUC vs. 3.2 (2.3-4.1) for PLA (p = .094) at 1 min and -1.2 (-1.7-0.7) for SUC vs. -0.8 (-1.5 to -0.1) for PLA (p = 0.66) at 3 min after NPA. For the Neonatal Infant Pain Scale scores, it was 2.3 (1.6-3.0) (SUC) vs. 2.5 (1.8-3.2) (PLA) (p = .086) at 1 min and -1.2 (-1.6 to -0.8) (SUC) vs. -0.8 (-1.3 to 0.2) (PLA) (p = 0.59) 3 min after NPA. There was no difference in the mean crying time, 114 (98-130) s, SUC vs. 109 (92-126) s, PLA (p = 0.81). No significant difference was found in participants' heart rate at 1 min 174 (154-194) beats/min in SUCvs. 179 (160-198) beats/min in PLA (p = 0.32). CONCLUSIONS: In infants (1-3 months) undergoing NPA, administration of an oral sweet solution did not statistically decrease pain scores.
RCT Entities:
BACKGROUND: Oral sweet solutions have been proposed as effective pain-reducing agents for procedures. OBJECTIVES: To compare the efficacy of an oral sucrose solution vs. placebo in alleviating pain in children (1-3 months) during nasopharyngeal aspiration (NPA). METHODS: A randomized, double-blind, controlled clinical trial was conducted in a pediatric hospital emergency department. Participants (aged 1-3 months) requiring NPA were randomly allocated to receive 2 mL of 88% sucrose (SUC) or 2 mL of a placebo (PLA) 2 min prior to the procedure. The primary outcome was the mean difference in pain scores at 1 min post NPA as assessed by the Face, Legs, Activity, Cry and Consolability (FLACC) Pain Scale. RESULTS: Seventy-two participants completed the study, 37 receiving SUC and 35 PLA. The mean difference in FLACC scores compared with baseline was 3.3 (2.5-4.1) for SUC vs. 3.2 (2.3-4.1) for PLA (p = .094) at 1 min and -1.2 (-1.7-0.7) for SUC vs. -0.8 (-1.5 to -0.1) for PLA (p = 0.66) at 3 min after NPA. For the Neonatal Infant Pain Scale scores, it was 2.3 (1.6-3.0) (SUC) vs. 2.5 (1.8-3.2) (PLA) (p = .086) at 1 min and -1.2 (-1.6 to -0.8) (SUC) vs. -0.8 (-1.3 to 0.2) (PLA) (p = 0.59) 3 min after NPA. There was no difference in the mean crying time, 114 (98-130) s, SUC vs. 109 (92-126) s, PLA (p = 0.81). No significant difference was found in participants' heart rate at 1 min 174 (154-194) beats/min in SUC vs. 179 (160-198) beats/min in PLA (p = 0.32). CONCLUSIONS: In infants (1-3 months) undergoing NPA, administration of an oral sweet solution did not statistically decrease pain scores.