BACKGROUND:Insertion of peripherally inserted central catheters (PICC) is a commonly performed procedure in both preterm and term infants. Tetracaine 4% gel (Ametop; Smith & Nephew Inc, St. Laurent, Quebec), a topical anesthetic, although reported to be effective for reducing the pain of venipuncture in neonates, has not been investigated for the management of pain associated with the PICC procedure. PURPOSE: To determine the efficacy of tetracaine gel for managing the pain associated with the PICC procedure in preterm and term infants. METHODS: A double-blind, placebo-controlled, randomized controlled trial (RCT) design was used. Infants undergoing nonurgent PICC insertion were randomized to receive either the treatment (1.0 g of tetracaine 4% gel) or placebo control (1.0 g of eucerin-plus cream) applied to the skin under occlusion for 30 minutes before the procedure. Data on the behavioral (facial expression) and physiologic (heart rate and oxygen saturation) indicators of pain were collected via videotaping and computer monitoring throughout the procedure. Data then were coded and measured by independent observers using the Premature Infant Pain Profile (PIPP; Stevens et al, 1996), and analyzed using descriptive statistics and repeated-measures analyses of variance. RESULTS:Forty-nine infants, gestational age 27 to 41 weeks (mean = 33; SD = 4.2) and age at time of insertion 2 to 85 days (mean = 18; SD = 22.5) participated. No differences were found between the groups at the time of randomization. There were no adverse cardiorespiratory events or local skin reactions in either group. There was a significant within-subjects main effect of time across the procedure (F[48,3] = 11.03; P < 0.0001). There was no significant between-subjects main effect of group (F[48,1] = 0.11; P = 0.74) and no (group x time) interaction (F[48,3] = 0.45; P = 0.72). CONCLUSION:Tetracaine gel was not effective for pain relief for PICC insertion in infants. Its use for pain relief cannot be recommended based on the results of this study. Other pharmacologic, behavioral, and physical interventions should be investigated for safety and relief of procedural pain in this population of infants.
RCT Entities:
BACKGROUND: Insertion of peripherally inserted central catheters (PICC) is a commonly performed procedure in both preterm and term infants. Tetracaine 4% gel (Ametop; Smith & Nephew Inc, St. Laurent, Quebec), a topical anesthetic, although reported to be effective for reducing the pain of venipuncture in neonates, has not been investigated for the management of pain associated with the PICC procedure. PURPOSE: To determine the efficacy of tetracaine gel for managing the pain associated with the PICC procedure in preterm and term infants. METHODS: A double-blind, placebo-controlled, randomized controlled trial (RCT) design was used. Infants undergoing nonurgent PICC insertion were randomized to receive either the treatment (1.0 g of tetracaine 4% gel) or placebo control (1.0 g of eucerin-plus cream) applied to the skin under occlusion for 30 minutes before the procedure. Data on the behavioral (facial expression) and physiologic (heart rate and oxygen saturation) indicators of pain were collected via videotaping and computer monitoring throughout the procedure. Data then were coded and measured by independent observers using the Premature InfantPain Profile (PIPP; Stevens et al, 1996), and analyzed using descriptive statistics and repeated-measures analyses of variance. RESULTS: Forty-nine infants, gestational age 27 to 41 weeks (mean = 33; SD = 4.2) and age at time of insertion 2 to 85 days (mean = 18; SD = 22.5) participated. No differences were found between the groups at the time of randomization. There were no adverse cardiorespiratory events or local skin reactions in either group. There was a significant within-subjects main effect of time across the procedure (F[48,3] = 11.03; P < 0.0001). There was no significant between-subjects main effect of group (F[48,1] = 0.11; P = 0.74) and no (group x time) interaction (F[48,3] = 0.45; P = 0.72). CONCLUSION:Tetracaine gel was not effective for pain relief for PICC insertion in infants. Its use for pain relief cannot be recommended based on the results of this study. Other pharmacologic, behavioral, and physical interventions should be investigated for safety and relief of procedural pain in this population of infants.
Authors: Daniella W E Roofthooft; Sinno H P Simons; Richard A van Lingen; Dick Tibboel; John N van den Anker; Irwin K H Reiss; Monique van Dijk Journal: Neonatology Date: 2017-05-31 Impact factor: 4.035