The minimally effective dose of sucrose for procedural pain relief in neonates: a randomized controlled trial.

BACKGROUND: Orally administered sucrose is effective and safe in reducing pain intensity during single, tissue-damaging procedures in neonates, and is commonly recommended in neonatal pain guidelines. However, there is wide variability in sucrose doses examined in research, and more than a 20-fold variation across neonatal care settings. The aim of this study was to determine the minimally effective dose of 24% sucrose for reducing pain in hospitalized neonates undergoing a single skin-breaking heel lance procedure. METHODS: A total of 245 neonates from 4 Canadian tertiary neonatal intensive care units (NICUs), born between 24 and 42 weeks gestational age (GA), were prospectively randomized to receive one of three doses of 24% sucrose, plus non-nutritive sucking/pacifier, 2 min before a routine heel lance: 0.1 ml (Group 1; n = 81), 0.5 ml (Group 2; n = 81), or 1.0 ml (Group 3; n = 83). The primary outcome was pain intensity measured at 30 and 60 s following the heel lance, using the Premature Infant Pain Profile-Revised (PIPP-R). The secondary outcome was the incidence of adverse events. Analysis of covariance models, adjusting for GA and study site examined between group differences in pain intensity across intervention groups. RESULTS: There was no difference in mean pain intensity PIPP-R scores between treatment groups at 30 s (P = .97) and 60 s (P = .93); however, pain was not fully eliminated during the heel lance procedure. There were 5 reported adverse events among 5/245 (2.0%) neonates, with no significant differences in the proportion of events by sucrose dose (P = .62). All events resolved spontaneously without medical intervention. CONCLUSIONS: The minimally effective dose of 24% sucrose required to treat pain associated with a single heel lance in neonates was 0.1 ml. Further evaluation regarding the sustained effectiveness of this dose in reducing pain intensity in neonates for repeated painful procedures is warranted. TRIAL REGISTRATION: ClinicalTrials.gov : NCT02134873. Date: May 5, 2014 (retrospectively registered).

Validation of the Premature Infant Pain Profile-Revised (PIPP-R).

OBJECTIVES: To examine the construct validity, inter-rater reliability, and feasibility of the Premature Infant Pain Profile-Revised in infants of varying gestational ages, diagnoses, and procedures. METHODS: A prospective cross-over study with infants in three gestational age groups (26-31, 32-36, and ≥37 weeks) at three university-affiliated Neonatal Intensive Care Units in Canada. One hundred and ninety five bedside nurses and expert raters rated 202 hospitalized infants' pain during scheduled procedures using the measure. An expert rater and a nurse independently assessed infants' pain scores, using the Premature Infant Pain Profile-Revised, during 246 scheduled pairs of painful and non-painful procedures in the 202 infants. Nurses also completed a feasibility survey on using the measure in a clinical setting. To establish construct validity, pain scores were computed during painful and non-painful procedures. Inter-rater reliability between pain experts and nurses was calculated. A 5-point Likert scale was used to measure feasibility in terms of clarity, ease of use, and time to complete. RESULTS: Irrespective of gestational age, Premature Infant Pain Profile-Revised scores were significantly higher during painful procedures (mean 6.7 [SD 3.0]) compared to non-painful procedures (mean 4.8 [SD 2.9]). There was a high degree of correlation between nurses' and experts' ratings for painful (all R(2)=0.92, p<0.001) and non-painful (all R(2)=0.87, p<0.001) procedures. Mean scores on all feasibility indicators were equal to or higher than 3.8. DISCUSSION: The Premature Infant Pain Profile Revised has beginning construct validation, inter-rater reliability, and is considered feasible by clinicians. Concurrent validation studies should be considered.

The premature infant pain profile-revised (PIPP-R): initial validation and feasibility.

OBJECTIVES: To describe revisions to the Premature Infant Pain Profile (PIPP) and initial construct validation and feasibility of the Premature Infant Pain Profile-Revised (PIPP-R). METHODS: The PIPP was revised to enhance validity and feasibility. To validate the PIPP-R, data from 2 randomized cross-over studies were utilized to: (1) calculate and compare PIPP and PIPP-R scores in extremely low gestational age infants undergoing a painful and nonpainful event (N=52; dataset #1) and (2) calculate and compare PIPP and PIPP-R scores in assessing the effectiveness of (a) sucrose, (b) non-nutritive sucking (NNS)+sucrose, and (c) facilitated tucking+NNS+sucrose during heel lance (N = 85; dataset #2). Pearson correlations between PIPP and PIPP-R scores were calculated, and Student t tests and 1-way analysis of variance were used to determine construct validity during painful and nonpainful events. To establish feasibility, a survey of 31 Neonatal Intensive Care Unit nurses was conducted. RESULTS: PIPP-R scores were significantly lower during nonpainful (mean, 8.3; SD = 2.9) compared with painful (mean, 9.9; SD=3.1; t95 = 4.51, P = 0.036) events in extremely low gestational age infants in dataset #1. In dataset #2, PIPP-R scores were significantly lower in infants 25 to 41 weeks gestation in the group receiving NNS+sucrose compared with the other 2 groups (F2,79 = 2.9, P<0.05). Overall, nurses rated the PIPP-R as feasible. DISCUSSION: Initial construct validation and feasibility of the PIPP-R was demonstrated. Further testing with infants of varying gestational ages, diagnoses, and pain conditions is required; as is exploration of PIPP-R in relation to other types of physiological and cognitive responses.