EFFECT ON PAIN OF AN ORAL SUCROSE SOLUTION VERSUS PLACEBO IN CHILDREN 1 TO 3 MONTHS OLD NEEDING NASOPHARYNGEAL ASPIRATION; A RANDOMIZED CONTROLLED TRIAL

BACKGROUND: Early recognition and treatment of pain among children is important for their cognitive development and their future response to pain throughout their life. Oral sweet solutions have been accepted as effective pain reducing agents for procedures in the neonatal population. Only infants undergoing venous puncture and bladder catheterization have been studied in the Emergency Department (ED) setting. These studies have reported conflicting results. No previous study has evaluated the utilization of sucrose to manage pain during nasopharyngeal aspiration (NPA).

OBJECTIVES: To compare the efficacy of an oral sucrose solution versus placebo in reducing pain in children 1 to 3 months of age during NPA in the ED.

DESIGN/METHODS: A randomized, double-blind, placebo controlled clinical trial was conducted in a tertiary care pediatric university-affiliated hospital ED. Participants from 1 to 3 months of age requiring NPA as part of their planned ED management were recruited and randomly allocated to receive 2 mls of an 88% sucrose solution (SUC) or 2 mls of a placebo solution (PLA) orally, 2 minutes before 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. Secondary outcomes were the difference in pain scores using the Neonatal Infant Pain Scale (NIPS), crying time, heart rate and adverse events. Based on previously reported data, using an alpha value of 0.05, a power of 90% and using a two point difference in mean FLACC scales as clinically significant difference, 33 patients per group were needed.

RESULTS: Seventy-two participants were recruited and completed the study, 37 (group SUC) and 35 (group PLA) respectively. Both groups had similar demographic and clinical characteristics and baseline FLACC and NIPS pain scores (all p values >0.4). The mean difference in FLACC scores compared to baseline was 3.3 (2.5–4.1) (SUC) vs. 3.2 (2.3–4.1) (PLA) (p=.94) at 1 min and -1.2 (-1.7 to 0.7) (SUC) vs. -0.8 (-1.5 to -0.1) (PLA) (p=.66) at 3 mins after NPA. For the NIPS scores, it was 2.3 (1.6–3.0) (SUC) vs. 2.5 (1.8–3.2) (PLA) (p=.86) at 1 min and -1.2 (-1.6 to -0.8) (SUC) vs. -0.8 (-1.3 to 0.2) (PLA) (p=.59) 3 mins after NPA. There was no difference in the mean crying time, 114 (98–130) secs (SUC) vs. 109 (92–126) secs (PLA) (p=.81). No significant difference was found in participants’ heart rate at 1 min 174 (154–194) BPM (SUC) vs. 179 (160–198) BPM (PLA) (p=.32) and at 3 mins 165 (143–187) BPM (SUC) vs. 164 (142–186) BPM (PLA) (p=.86) after NPA. Three patients had vomiting during the procedure (2 PLA and 1 SUC), and one had an episode of chocking (PLA). No other adverse events were reported.

CONCLUSION: In infants 1 to 3 months of age undergoing nasopharyngeal aspiration in the ED, administration of an oral sweet solution did not statistically decrease pain scores as measured by the FLACC and NIPS scales. Participants’ heart rate and crying time were not significantly decreased when sucrose was provided.