NDLI: Topical amethocaine gel 4% for intramuscular injection in term neonates: a double-blind, placebo-controlled, randomized trial.

Please wait, while we are loading the content...

Comparative bioavailability of single-dose methylphenidate from a multilayer-release bead formulation and an osmotic system: a two-way crossover study in healthy young adults.

Analgesic effectiveness of celecoxib and diclofenac in patients with osteoarthritis of the hip requiring joint replacement surgery: a 12-week, multicenter, randomized, double-blind, parallel-group, double-dummy, noninferiority study.

Effects of fluvastatin extended-release (80 mg) alone and in combination with ezetimibe (10 mg) on low-density lipoprotein cholesterol and inflammatory parameters in patients with primary hypercholesterolemia: a 12-week, multicenter, randomized, open-label, parallel-group study.

Comparison of the effects of doxazosin and atenolol on target organ damage in adults with type 2 diabetes mellitus and hypertension in the CARDHIAC study: a 9-month, prospective, randomized, open-label, blinded-evaluation trial.

Ambulatory blood pressure-lowering effects of valsartan and enalapril after a missed dose in previously untreated patients with hypertension: a prospective, randomized, open-label, blinded end-point trial.

A case-control study of the association between polymorphisms of the endothelial nitric oxide synthase and glycoprotein IIIa genes and upper gastrointestinal bleeding in users of low-dose aspirin.

Two single-center, double-blind, randomized, placebo-controlled, phase I studies to investigate the tolerability and pharmacokinetics of CH-1504, an antifolate, in healthy male subjects.

Colistin serum concentrations after intravenous administration in critically ill patients with serious multidrug-resistant, gram-negative bacilli infections: a prospective, open-label, uncontrolled study.

Risk factors for hyperglycemia in hospitalized adults receiving gatifloxacin: a retrospective, nested case-controlled analysis.

How Connecticut primary care physicians view treatments for streptococcal and nonstreptococcal pharyngitis.

Topical amethocaine gel 4% for intramuscular injection in term neonates: a double-blind, placebo-controlled, randomized trial.

Open-label, prospective, randomized comparison of propofol and sevoflurane for laryngeal mask anesthesia for magnetic resonance imaging in pediatric patients.

Donepezil use in children and adolescents with tics and attention-deficit/hyperactivity disorder: an 18-week, single-center, dose-escalating, prospective, open-label study.

Alzheimer's disease: the specter of fragmented policy and financing.

Cardiovascular outcomes among patients newly initiating atorvastatin or simvastatin therapy: a large database analysis of managed care plans in the United States.

Use of darbepoetin alfa and epoetin alfa in clinical practice in patients with cancer-related anemia.

The effects of direct-to-consumer advertising of statins on the attainment of low-density lipoprotein cholesterol goals.

Year: 2008 Volume: 30 Issue: Supplementary C

Year: 2008 Volume: 30 Spec No

Year: 2008 Volume: 30 Pt 2

Year: 2007 Volume: 29

Topical amethocaine gel 4% for intramuscular injection in term neonates: a double-blind, placebo-controlled, randomized trial.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Shah, Vibhuti S. Taddio, Anna Hancock, Rebecca Shah, Prakeshkumar Ohlsson, Arne
Spatial Coverage	Ontario
Description	Country affiliation: Canada Author Affiliation: Shah VS ( Department of Paediatrics, Mount Sinai Hospital, Toronto, Ontario, Canada. vshah@mtsinai.on.ca)
Abstract	BACKGROUND: Topical local anesthetic agents such as amethocaine penetrate intact skin and block pain signals originating from the dermis during medical procedures. They have been found to attenuate pain from various procedures, including intramuscular (i.m.) injection of vaccines. Published data on their effectiveness for i.m. injection of vitamin K in neonates were not identified. OBJECTIVES: The primary objective of this study was to evaluate the analgesic effectiveness and tolerability of topical amethocaine gel 4% in neonates undergoing i.m. injection of vitamin K. The secondary objective was nurses' response to the use of the intervention and possible barriers associated with its incorporation into clinical practice. METHODS: In a double-blind, placebo-controlled, randomized trial, full-term neonates in the Labor and Delivery Unit of Mount Sinai Hospital, Toronto, Ontario, Canada, received 1 g of amethocaine gel 4% or placebo 30 minutes prior to i.m. injection of 0.5 mL of vitamin K. Pain responses were assessed using percent facial grimacing score, percent cry duration, and latency to cry from video recordings. Parents and nurses assessed infants' pain response using a visual analog scale (VAS). Local adverse events (ie, erythema, blanching) at the application site were recorded. Nurses were asked to provide written responses regarding their willingness to incorporate local anesthetics in clinical practice and barriers to their use. RESULTS: From July 2003 to December 2004, 175 families were approached for participation in the study; 52 declined consent and 13 were not randomized. One hundred ten neonates were enrolled and evenly randomized to each group. Baseline characteristics were similar in both groups. During i.m. injection, the mean (SD) percent facial grimacing score was 70% (30%) for the amethocaine group compared with 75% (34%) for the placebo group (P = 0.41). The mean (SD) for percent cry duration was 55% (34%) compared with 62% (38%), respectively (P = 0.34). The mean (SD) latency to cry was significantly longer in the amethocaine group compared with the placebo group (4.7 [4.5] vs 2.7 [2.3] seconds; P = 0.01). Parents' and nurses' VAS ratings for infant pain did not differ between groups. The incidence of adverse events did not differ between groups. Ninety-seven percent of nurses (89/92) said they would use the intervention. Fifty-seven percent of nurses (52/92) identified barriers to incorporation with the primary reason being time constraint (67% [35/52]). CONCLUSIONS: Topical amethocaine gel 4% was ineffective in reducing pain on i.m. injection of vitamin K in these full-term neonates. Treatment was generally well tolerated and nurses concluded that, given the choice, they would use a topical anesthetic.
File Format	HTM / HTML
ISSN	01492918
Issue Number	1
Volume Number	30
e-ISSN	1879114X
Journal	Clinical Therapeutics
Language	English
Publisher	Elsevier
Publisher Date	2008-01-01
Publisher Place	United States
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Pharmacology Anesthetics, Local Therapeutic Use Injections, Intramuscular Adverse Effects Pain Prevention & Control Tetracaine Administration, Topical Attitude Of Health Personnel Crying Double-blind Method Facial Expression Gels Humans Infant, Newborn Neonatal Nursing Ontario Pain Measurement Vitamin K Administration & Dosage Vitamins Journal Article Randomized Controlled Trial Research Support, Non-u.s. Gov't
Content Type	Text
Resource Type	Article
Subject	Pharmacology Pharmacology (medical)

Sl.	Authority	Responsibilities	Communication Details
1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
5	Website/Portal (Helpdesk)	Queries regarding NDLI and its services	support@ndl.gov.in
6	Contents and Copyright Issues	Queries related to content curation and copyright issues	content@ndl.gov.in
7	National Digital Library of India Club (NDLI Club)	Queries related to NDLI Club formation, support, user awareness program, seminar/symposium, collaboration, social media, promotion, and outreach	clubsupport@ndl.gov.in
8	Digital Preservation Centre (DPC)	Assistance with digitizing and archiving copyright-free printed books	dpc@ndl.gov.in
9	IDR Setup or Support	Queries related to establishment and support of Institutional Digital Repository (IDR) and IDR workshops	idr@ndl.gov.in

Lidocaine/tetracaine patch (Rapydan) for topical anaesthesia before arterial access: a double-blind, randomized trial.

Topical anaesthesia and intravenous cannulation success in paediatric patients: a randomized double-blind trial.

Effect of topical alkane vapocoolant spray on pain with intravenous cannulation in patients in emergency departments: randomised double blind placebo controlled trial

Avoiding propofol injection pain in children: a prospective, randomized, double-blinded, placebo-controlled study.

Effect of time on clinical efficacy of topical anesthesia.

Efficacy of Benzocaine 20% Topical Anesthetic Compared to Placebo Prior to Administration of Local Anesthesia in the Oral Cavity: A Randomized Controlled Trial.

A randomized, double-blind, placebo-controlled trial of sclerosing injections in patients with chronic low back pain

Magnesium sulfate with lidocaine for preventing propofol injection pain: a randomized, double-blind, placebo-controlled trial.

Intranasal Topical Local Anesthetic and Decongestant for Flexible Nasendoscopy in Children: A Randomized, Double-blind, Placebo-Controlled Trial

Topical amethocaine gel 4% for intramuscular injection in term neonates: a double-blind, placebo-controlled, randomized trial.

Similar Documents

Lidocaine/tetracaine patch (Rapydan) for topical anaesthesia before arterial access: a double-blind, randomized trial.

Topical anaesthesia and intravenous cannulation success in paediatric patients: a randomized double-blind trial.

Effect of topical alkane vapocoolant spray on pain with intravenous cannulation in patients in emergency departments: randomised double blind placebo controlled trial

Avoiding propofol injection pain in children: a prospective, randomized, double-blinded, placebo-controlled study.

Effect of time on clinical efficacy of topical anesthesia.

Efficacy of Benzocaine 20% Topical Anesthetic Compared to Placebo Prior to Administration of Local Anesthesia in the Oral Cavity: A Randomized Controlled Trial.

A randomized, double-blind, placebo-controlled trial of sclerosing injections in patients with chronic low back pain

Magnesium sulfate with lidocaine for preventing propofol injection pain: a randomized, double-blind, placebo-controlled trial.

Intranasal Topical Local Anesthetic and Decongestant for Flexible Nasendoscopy in Children: A Randomized, Double-blind, Placebo-Controlled Trial

Topical amethocaine gel 4% for intramuscular injection in term neonates: a double-blind, placebo-controlled, randomized trial.