Topical Amethocaine Gel for Intramuscular Injection in Term Neonates
|ClinicalTrials.gov Identifier: NCT00267111|
Recruitment Status : Completed
First Posted : December 20, 2005
Results First Posted : April 23, 2012
Last Update Posted : April 23, 2012
This study will examine the efficacy of topical amethocaine gel (Ametop) in decreasing the pain response in term neonates subjected to intramuscular injection for administration of vitamin K.
Study Hypothesis: We believe that topical amethocaine gel will be superior to placebo in decreasing the pain from intramuscular injection in term neonates.
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: Eucerin plus Drug: Amethocaine gel 4%||Phase 2|
This randomized controlled trial will assess the efficacy of topical amethocaine gel (Ametop) compared with placebo (Eucerin plus) in decreasing the pain response in term neonates subjected to intramuscular injection for administration of vitamin K. Neonatal pain response between groups will be assessed using the Neonatal Facial Action Coding System (NFCS) which is currently the gold standard for infant pain assessment, latency to first cry and cry duration. Parents' (father) perception of infant's pain will be assessed using a visual analogue scale (VAS) when possible.
Neonates will be randomized to receive either amethocaine gel or identical appearing placebo administered locally at the injection site (the upper part of the neonate's thigh) using a pre-prepared syringe 30 minutes prior to the administration of vitamin K. The gel or placebo will be covered using a Saran wrap. Each neonate will be videotaped during the procedure. Parents (father) will be present during the procedure (observing) so that they (he) can assess their neonate's pain response using VAS.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Local Anaesthesia [Topical Amethocaine Gel (Ametop)] for Intramuscular Injection in Term Neonates: A Randomized Controlled Trial.|
|Study Start Date :||July 2003|
|Primary Completion Date :||December 2004|
|Study Completion Date :||December 2004|
Experimental: Amethocaine gel 4% Group
1 g of topical amethocaine gel 4%
Drug: Amethocaine gel 4%
1 g, single application
Other Name: Ametop
|Placebo Comparator: Placebo Group||
Drug: Eucerin plus
1g, single application
- Pain Scores Assessed by Neonatal Facial Action [ Time Frame: For the purpose of analysis IM injection procedure was divided into 4 phases: baseline , cleansing, injection and recovery phases.. For each phase facial actions were scored for the first 20 seconds or less if the phase lasted < 20 seconds. ]The presence or absence of 3 facial actions (brow bulge, eyes squeeze and deepening of the nasolabial furrow) were scored in 2 second intervals for the first 20 seconds (or less if the phase lasted < 20 seconds) of each procedure phase from the videotapes by a trained research assistant. The data were then collapsed for each facial action into the percentage of time the infant expressed the action. An overall pain score was computed by summing the percentage scores for the three facial actions and then dividing by three. The score ranged from 0% to 100% with higher values suggesting more pain.
- Visual Analogue Scale [ Time Frame: During the entire procedure ]Parents and nurses were asked to assess the infant's pain response during the procedure using Visual analogue scale (VAS) on an unmarked horizontal 10 cm continuous line where 0="no pain" on the left side and 10="worst possible pain" on the right side. Parents and nurses were trained to use the VAS prior to the IM injection.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00267111
|Mount Sinai Hospital|
|Toronto, Ontario, Canada, M5G 1X5|
|Principal Investigator:||Vibhuti S Shah, MD, FRCPC||Mount Sinai Hospital, New York|