M Pandey1, V Datta, H S Rehan. 1. Department of Pediatrics, Lady Hardinge Medical College and associated Kalawati Saran Children's Hospital, New Delhi 110001, India. dr_meenu_pandey@yahoo.com
Abstract
OBJECTIVES: To study whether orogastric tube (OGT) insertion elicits a painful response in preterm neonates, and the role of oral sucrose in reducing this pain. METHODS: This double blinded, randomized control trial was conducted in the neonatal intensive care units of Kalawati Saran Children's Hospital. Clinically stable preterms within the first 7 postnatal days, who had not received painful stimulus 30 min prior to intervention, and who required routine OGT insertion were included. Lingual 24 % sucrose or distilled water (1 ml) was administered 2 min before OGT insertion. The primary outcome was painful response assessed by Premature Infant Pain Profile scale (PIPP), while the secondary outcomes were heart rate and SpO2 changes. The trial is registered with ClinicalTrials.gov ( REGISTRATION NUMBER: NCT 00949104) RESULTS:Sixty preterms were randomized in each group. Final analysis was carried out on 52 subjects in the placebo group and 53 in the sucrose group. The mean intra-procedure PIPP scores were significantly higher than the mean pre-procedure PIPP scores, in the gestational age groups of more than 34 wk, and 32 wk to 33 wk, 6 d, in both the placebo (7.25 vs. 3, and 8.14 vs. 3.14, respectively) and sucrose arm (8.06 vs. 3.21, and 7.18 vs. 4.18, respectively). The mean PIPP scores assessed at 30 s post procedure in the sucrose group were significantly lower than the placebo group (4.32 vs. 5.6, p = 0.014). No significant adverse events were seen. CONCLUSIONS: OGT insertion causes pain in preterms and single dose lingual 24 % sucrose may alleviate this pain.
RCT Entities:
OBJECTIVES: To study whether orogastric tube (OGT) insertion elicits a painful response in preterm neonates, and the role of oral sucrose in reducing this pain. METHODS: This double blinded, randomized control trial was conducted in the neonatal intensive care units of Kalawati Saran Children's Hospital. Clinically stable preterms within the first 7 postnatal days, who had not received painful stimulus 30 min prior to intervention, and who required routine OGT insertion were included. Lingual 24 % sucrose or distilled water (1 ml) was administered 2 min before OGT insertion. The primary outcome was painful response assessed by Premature InfantPain Profile scale (PIPP), while the secondary outcomes were heart rate and SpO2 changes. The trial is registered with ClinicalTrials.gov ( REGISTRATION NUMBER: NCT 00949104) RESULTS: Sixty preterms were randomized in each group. Final analysis was carried out on 52 subjects in the placebo group and 53 in the sucrose group. The mean intra-procedure PIPP scores were significantly higher than the mean pre-procedure PIPP scores, in the gestational age groups of more than 34 wk, and 32 wk to 33 wk, 6 d, in both the placebo (7.25 vs. 3, and 8.14 vs. 3.14, respectively) and sucrose arm (8.06 vs. 3.21, and 7.18 vs. 4.18, respectively). The mean PIPP scores assessed at 30 s post procedure in the sucrose group were significantly lower than the placebo group (4.32 vs. 5.6, p = 0.014). No significant adverse events were seen. CONCLUSIONS: OGT insertion causes pain in preterms and single dose lingual 24 % sucrose may alleviate this pain.
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