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benzocaine

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Description

Benzocaine: A surface anesthetic that acts by preventing transmission of impulses along NERVE FIBERS and at NERVE ENDINGS. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

dextran sulfate sodium : An organic sodium salt of dextran sulfate. It induces colitis in mice. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

benzocaine : A benzoate ester having 4-aminobenzoic acid as the acid component and ethanol as the alcohol component. A surface anaesthetic, it is used to suppress the gag reflex, and as a lubricant and topical anaesthetic on the larynx, mouth, nasal cavity, respiratory tract, oesophagus, rectum, urinary tract, and vagina. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Cross-References

ID SourceID
PubMed CID2337
CHEMBL ID278172
CHEBI ID116735
SCHEMBL ID25100
MeSH IDM0002353

Synonyms (582)

Synonym
MLS001331704
smr000059025
MLS002153970
BB 0258778
BRD-K75466013-001-05-2
4-(ethoxycarbonyl)aniline
orthesin
ora-jel
p-aminobenzoic acid, ethyl ester
anestezin
anaesthin
nsc4688
nsc-4688
wln: zr dvo2
americaine
ethyl p-aminophenylcarboxylate
ethoform
hurricaine
anesthesin
amben ethyl ester
keloform
norcain
4-aminobenzoic acid, ethyl ester
anesthone
p-carbethoxyaniline
parathesin
norcaine
ethyl p-aminobenzoate
anaesthan-syngala
p-(ethoxycarbonyl)aniline
anaesthesin
anesthesine
solu h
topcaine
identhesin
ethyl 4-aminobenzoate ,
parathesine
dermoplast
4-carbethoxyaniline
p-ethoxycarboxylic aniline
benzoic acid, 4-amino-, ethyl ester
benzoic acid, p-amino-, ethyl ester
nsc-41531
nsc41531
KBIO1_000932
DIVK1C_000932
dextran sulfate sodium (dst-h)
dextran sulfate sodium (kmds-h)
dextran sulfate sodium (ds-m-1)
dextran, hydrogen sulfate, sodium salt
dextran sulfate sodium
vagisil
SPECTRUM_000074
ethylester kyseliny p-aminobenzoove [czech]
anestezin [russian]
ethoforme
epa pesticide chemical code 097001
ai3-02081
benzocaina [inn-spanish]
einecs 202-303-5
caswell no. 430a
baby anbesol
ethylis aminobenzoas
anaesthesinum
outgro
ethyl aminobenzoate (van)
norcainum
p-aminobenzoic acid ethyl ester
brn 0638434
benzocainum [inn-latin]
hsdb 7225
aethylium paraminobenzoicum
ethyl paba
bensokain
nsc 41531
PRESTWICK_991
NCGC00016352-01
cas-94-09-7
OPREA1_827402
IDI1_000932
OPREA1_750694
BSPBIO_000923
BSPBIO_001908
PRESTWICK3_000712
SPECTRUM5_000860
PRESTWICK2_000712
9011-18-1
AB00051923
defend
94-09-7
C07527
benzocaine
ethyl aminobenzoate
4-aminobenzoic acid ethyl ester
DB01086
ethyl aminobenzoate (jp17)
parathesin (tn)
D00552
benzocaine (usp/inn)
NCGC00094598-02
NCGC00094598-01
KBIO2_005610
KBIOGR_000658
KBIO3_001408
KBIO2_003042
KBIO2_000474
KBIOSS_000474
SPBIO_002844
PRESTWICK0_000712
SPECTRUM4_000249
SPECTRUM2_000117
SPBIO_000134
PRESTWICK1_000712
NINDS_000932
SPECTRUM3_000314
SPECTRUM1500139
BPBIO1_001017
flavamed
p-aminobenzoic ethyl ester
ethyl 4-aminobenzoate, 98%
STK043620
HMS2091M11
CHEBI:116735 ,
benzocainum
benzocaina
A0271
CHEMBL278172
ar-01
ar01
subcutin
HMS502O14
FT-0662548
HMS1570O05
HMS1920G09
AKOS000119763
AE-562/40377256 ,
HMS2097O05
4-amino-benzoic acid ethyl ester
dtxsid8021804 ,
dtxcid301804
tox21_301149
NCGC00255047-01
pharmakon1600-01500139
nsc755909
nsc-755909
tox21_110391
HMS2233H21
S4210
CCG-38918
NCGC00016352-03
NCGC00016352-04
NCGC00016352-02
aethoform
otocain
benzocaine [usp:inn:ban]
finafta
unii-u3rsy48jw5
chloraseptic
u3rsy48jw5 ,
ethylester kyseliny p-aminobenzoove
4-14-00-01129 (beilstein handbook reference)
FT-0624536
FT-0625762
benzocaine [hsdb]
benzocaine [usp-rs]
benzocaine [vandf]
benzocaine [usp monograph]
ethyl aminobenzoate [jan]
benzocaine [mi]
benzocainum [who-ip latin]
aminobenzoic acid impurity b [ep impurity]
benzocaine [mart.]
benzocaine [who-ip]
benzocaine [who-dd]
benzocaine [inn]
benzocaine [ep monograph]
ethyl paba [inci]
EPITOPE ID:114084
HMS3371D08
ethyl4-aminobenzoate
SCHEMBL25100
tox21_110391_1
NCGC00016352-07
CS-B0934
HY-Y0258
ethyl-p-aminobenzoate
4-carboethoxyaniline
4-amino benzoic acid ethyl ester
ethyl-4-aminobenzoate
ethyl 4aminobenzoate
4-aminobenzoic acid-ethyl ester
ethyl 4-amino-benzoate
ethyl-p-amino-benzoate
p-amino benzoic acid ethyl ester
4-ethoxycarbonylaniline
ethyl 4-aminobenzate
ethyl 4-aminobezoate
ethyl p-amino-benzoate
ethyl 4-(amino)benzoate
p-ethoxycarbonylaniline
Q-200688
vagisil (salt/mix)
component of solarcaine aerosol (salt/mix)
cough-x (salt/mix)
component of anbesol maximum strength (salt/mix)
component of tympagesic (salt/mix)
outgro (salt/mix)
anbesol (salt/mix)
AB00051923_09
AB00051923_10
mfcd00007892
F2190-0448
benzocaine, european pharmacopoeia (ep) reference standard
AC-8127
SR-05000001573-3
sr-05000001573
benzocaine, tested according to ph.eur.
benzocaine, purum, >=99.0% (hplc)
ethyl 4-aminobenzoate, saj first grade, >=99.0%
benzocaine, united states pharmacopeia (usp) reference standard
HMS3652H13
ethyl 4-aminobenzoic acid
orabase-b
4-(ethoxycarbonyl)phenylamine
(p-(ethoxycarbonyl)phenylamine
ethyl p-aminobenzoic acid
ethyl p-aminobenzenecarboxylate
diet ayds
benzoak
SR-05000001573-1
sampl3, g4
bdbm197282
ethyl 4-aminobenzoate, 98.0-101.0%
ethyl 4-aminobenzoate, vetec(tm) reagent grade, 98%
benzocaine, pharmaceutical secondary standard; certified reference material
benzocaine 1.0 mg/ml in acetonitrile
SBI-0051293.P003
HMS3714O05
SW197074-3
Q422745
ethyl aminobenzoic acid
BRD-K75466013-001-08-6
A14560
EN300-16170
STR01509
HMS3885B11
A930377
A860898
mouth sore medication
allegenal-m
benzocain
hims delay wipes
brace relief
chloraseptic warming honey lemon
shungamale genital desensitizer
stallion
lollicaine bubble gum
benzocaine 10.0%
oral pain relief gel
ez access
topical anestheticraspberry
goodwinol
benzo-jelmint
little colds sore throat relief melt aways
massage men gel max size
benzocaine (ep monograph)
chloraseptic warming green tea
body action products endless love for men
comfortcaine topical anesthetic
male desensitizerpleasure balm
boil ease
kank-a
kolorz topical anestheticcotton candy
walgreens pain relieving for boils
nene dente
bite and sting relief
athoforme
atopalm oral pain relief
smartpractice topical anesthetic gelmint
d04ab04
equate oral pain relief
patterson dental topical anesthetic
gingicaine gel, pina colada flavor
top quality mfg. topical anesthetic
benzocaine 6%
signature care bite and sting relief
family dollaroral pain relief
sting and bite
scotts select topical anesthetic
benzo-jelraspberry
ismile topical anesthetic
ky duration for him
bite reliefscherer labs
alpha-cainetopical anesthetic
topexmint
benzo-jelstrawberry
benzocaine (usp:inn:ban)
stay hard
cvs oral anesthetic
topical anestheticbubble gum
orajelmaximum strength
instant erection
hurricainetopical anesthetic gel
zilactin-b
ejectdelaygel
topcaremaximum strength
cvs fast acting baby teething
ms topical anesthetic
jo prolonger with benzocaine
gingicaine gel, cherry flavor
body action products higher control male climax
orajel instant pain relief
candee caine topical anesthetic
my fair baby oral gelinstant pain relief
iodent oral analgesic
leader oral analgesic
preboost
men delay wipe
dental relief
gingicaine gel banana flavor
benzocaine (mart.)
myderm bite relief
makesensejunior pain relief
anal glide
ioline
sally hansen ouch-reliefwax kit
tiger supply inc topical anesthetic
smartpractice topical anesthetic gelpina colada
promescent delay wipes
sally hansen ouch-relief stripless hard wax kit
endless love for men
r02ad01
oral b instant pain relief
dental city topical anesthetic
topicale xtra
mark 3
ombre men overtime wipes
zip topical anesthetic gel mint
gingicaine gel
safco sensicaine ultra topical anesthetic gel
family wellnessregular
smartpractice topical anesthetic gelraspberry
blt 1
bite and sting reliefsignature care
rexallmaximum strength
topical anestheticpina colada
astra-dent topical anesthetic gel
ultimate erection enhancer
7 select oral pain maximum strength relief
gingicaine gel, cherry
roman swipes
anesgerm la muela
smartpractice topical anesthetic gelcherry
walgreens pain relief
opahl
my fair babyinstant pain relief
gingicaine gel, mint julep flabvor
dentek instant pain relief
mouth sore relief
ipana 20% benzocaine topical
kolorz topical anesthetictriple mint
iolite
kolorz topical anestheticblue rasberry
shungasensation balm
benzocaine 10%
olp baby teething
lollicaine mint
massage men gel max delay
ultracareoral anesthetic bubble gum
benzocaine gel
gingicaine gel, mint julep
tanac oral pain reliever
gumnumb topical anesthetic
quality choice maximum strength oral pain relieving
chigger relief
bite and sting medicated relief padscvs
desensitizing lubricant
assist iianorectal (hemorrhoidal)
topical anestheticstrawberry
intimate wipe
health-tec topical anesthetic
anesgerm la muelafast pain relief
baby anestenka
ultracareoral anesthetic orange cream
precaine b chocolate vanilla
precaine b chocolate mint
oral pain reliever
chigg away
smartpractice topical anesthetic gelbubble gum
oral gelmaximum strength
mint rx endurance wipes
alpha-caine
neuromedfa
prolong
trojan extended pleasure
orajel for toothachemaximum strength
rite aid tooth and gum pain relief
rite aid liquid anesthetic oral pain relief
gelato anestesico topical gel
topcare oral pain reliefmaximum strength
franklynumb 1
nrg topical anesthetic
walgreensmaximum strength
benzo-jelpina colada
neuromed
tokisansore throat relief
red cross canker sore
higher control male climax control lubricating
bite and sting reliefgnp
advance topical anesthetic gel
c05ad03
gingicaine gel, pina colada
orajel instant pain reliefregular
carmex cold sore treatment external analgesic
anesgerm
topexcherry
massage men gel max time
mandelaymale genital desensitizer
delay creme
gingicaine liquid, cherry flavor
benz o sthetic
kolorz topical anesthetic
intimale benzocaine delay gel
assist ii
hurricainetopical anesthetic liquid
rite aid tooth and gum pain reliefcushions
benzocainestrawberry
anbesolmaximum strength
kolorz topical anestheticpina colada
budpak oral maximum strength
sally hansen ouch-reliefwax strip kit
cvs maximum strength boil relief
makesensepain relief
gingicaine gel strawberry
jianze sting relief pads
sensicaine tm extratopical anesthetic
chiggerex
lollicaine pina colada
benzocainecherry
climax controlbenzocaine
sta-hard
benzo-jelcherry
winco foods maximum strength oral analgesic
blistex baby kanka
purelife topical anesthetic
lollicaine cherry
benzocainebubble gum
topical anestheticmint
topical anesthetic
gingicaine gel strawberry flavor
benzocaine 20%
ultracare anesthetic gel
mckesson orasol gel
stingx
pleasure balm
bite and sting reliefwell at walgreens
finaftamultioral
onetouch revolutiontopical anesthetic
kank-amouth pain
leader oral pain reliefanesthetic
body action products anal glide extra
goyescas 7 syrupssore throat relief
oralabs cold sore treatment
precaine b
benzocaine-5.00%
certus sting relief prep pad
benzodent
gingicaine gel, chocolate mint
primo topical anesthetic
optimum rock hard cream
anal blu
sally hansen ouch-relief numbing wipes
benzocainepina colada
endless lovefor men
benzocaineraspberry
eclipse topical analgesicfa
ky duration for men
budpak baby teething oral pain reliever
mouth sore relief applicator
benzocainum (inn-latin)
ultracareoral anesthetic walterberry
bactimicina for sore throat
sally hansen ouch-relief wax strip kit
topexraspberry
mouth sore reliefprofessional strength
comfortox benzocaine
lights sting relief prep pad
anal-ese
terrasil boil pain relief
n01ba05
cainetips
dentek instant pain reliefmaximum strength
adventure medical kits dental medic
rite aidprofessional strength
desensitizer
vistacaine topical anesthetic
anestenka
topical anestheticcherry
magic stamina climax control
gelato topical anesthetic
benzocaine 7.5%
climax control
sting relief prep pad
smartpractice topical anesthetic gelstrawberry
precaine b bubblegum
anadent kanka gel
warrior chiggerex relief
walgreenssevere oral pain reliever
benzocainemint
benzo-jelbubble gum
sheffield pain relief
goodsense oral pain relief
monistat care instant itch relief
boy butterdesensitizing lubricant
prime-gel
topcare oral pain relief
burkhart topical anesthetic
xpect sting wipes
gingicaine gel, chocolate mint flavor
chiggerex 2x medicated
bencocaine topical anesthetic
boy butterextreme desensitizing lubricant
dzeus climax control wipes
body action products climax control gel
salivacaine
gingicaine fusion
massage men gel max power
pleasure balmkama sutra
chigger reliefevora labs
benzo-jel
dermawound wound care venous stasis
blistex kank-eze
ultracare
anestesico topical gel
lubelife climax control delay
skins delay climax control benzocaine gel
sorbet anestesico topical gel
benzocaine 5.00%
red cross oral pain relief
sally hansen microwavable eybrow, face and lip wax kit
magic stamina
gingicaine gel, cotton candy flavor
nbe anbesol
benzocaine (usp-rs)
topexstrawberry
zip topical anesthetic gel strawberry
gingicaine liquid, cherry
20/20topical anesthetic
good neighbor pain relief
goyescas broncovac 5sore throat relief
herbasoul male genital desensitizer cream
topexbubble gum
topical anestheticbanana
gingicaine gel variety pak
benzocaina (inn-spanish)
cream desensitizer
benzocaine (usp monograph)
rexall
body action products butt eze benzocaine
benzocaine topical anesthetic
gps topical anesthetic
prolong plus
baby teething oral pain reliever
orajel severe toothachemaximum strength fast-acting formula
powerect benzocaine male delay gel
topicale
benzo jel
quala topical anesthetic gel
boy butterextreme h2o desensitizing lubricant
topexpina colada
cvs pharmacymaximum strength
midway select topical anesthetic
kolorz topical anestheticcherry burst
body action products prolong lubricating
benzocaine 3.5%
realtree
hurricainetopical anesthetic
benzocaine wipes
aethylis aminobenzoas
dextransulfatesodiumsalt
Z54178706
benzocaine, 1mg/ml in methanol

Research Excerpts

Overview

Benzocaine (BZC) is a local anaesthetic drug coupled with numerous adverse effects, and thus poses a great challenge for its simple and highly sensitive detection. It has been reported to cause toxic methaemoglobinaemia in otherwise healthy individuals with no predisposing risk factors.

ExcerptReferenceRelevance
"Benzocaine (BZC) is a local anaesthetic drug coupled with numerous adverse effects, and thus poses a great challenge for its simple and highly sensitive detection. "( Highly sensitive determination of anesthetic drug benzocaine based on hydroxypropyl-β-cyclodextrin-carbon black nanohybrids.
Cao, H; Chen, Y; Huang, Y; Wang, Z; Yu, L, 2022
)
2.42
"Benzocaine is a widely used topical oropharyngeal anesthetic and has been reported to cause methemoglobinemia. "( Evaluation and management of acquired methemoglobinemia associated with topical benzocaine use.
Ashraf, Z; Taleb, M; Tinkel, J; Valavoor, S, 2013
)
2.06
"Benzocaine is a common topical anesthetic that has the ability to induce methemoglobinemia (MetHgb) in large doses. "( Methemoglobinemia Secondary to Topical Benzocaine Application to Gastrostomy Site.
Barker, K; Benitez, JG; Lipton, M; Szlam, SM, 2016
)
2.15
"Benzocaine is a frequent cause of iatrogenic methemoglobinemia."( Topical Benzocaine and Methemoglobinemia.
Afeld, JL; Cumpston, KL; Hieger, MA; Wills, BK,
)
1.29
"Benzocaine is a widely used topical anaesthetic and has been reported to cause toxic methaemoglobinaemia in otherwise healthy individuals with no predisposing risk factors. "( Benzocaine-induced methaemoglobinaemia: a case study.
Bittmann, S; Krüger, C,
)
3.02
"Benzocaine (BZC) is a local anesthetic whose low water-solubility limits its application to topical formulations."( Physico-chemical characterization of benzocaine-beta-cyclodextrin inclusion complexes.
de Paula, E; Fraceto, LF; Junior, SO; Pertinhez, TA; Pinto, LM; Santana, MH, 2005
)
1.32
"Benzocaine is a commonly used topical anesthetic present in many over-the-counter preparations. "( Unexpected cyanosis in the surgical patient.
Douglass, HO; Lee, JS; Mendez, PA, 2000
)
1.75

Effects

Benzocaine has a long history of use in human medicine. It has structural similarities to methemoglobin (MHb)-forming drugs that are current candidates for cyanide prophylaxis. LC has been reported to increase MHb in man.

ExcerptReferenceRelevance
"Benzocaine has a long history of use in human medicine. "( The in vitro and in vivo genotoxicity of benzocaine: a brief communication.
Bell, TA; Brock, WJ, 2012
)
2.09
"Benzocaine has been proposed as an alternative sedative because a withdrawal period may not be required."( Benzocaine-induced methemoglobinemia in an acute-exposure rat model.
Beland, FA; Doerge, DR; Greenlees, KJ; Von Tungeln, LS; Woodling, KA; Zhou, T, 2011
)
2.53
"Benzocaine has a long history of use in human medicine. "( The in vitro and in vivo genotoxicity of benzocaine: a brief communication.
Bell, TA; Brock, WJ, 2012
)
2.09
"Benzocaine has structural similarities to methemoglobin (MHb)-forming drugs that are current candidates for cyanide prophylaxis, while LC has been reported to increase MHb in man."( Topical anesthetic-induced methemoglobinemia and sulfhemoglobinemia in macaques: a comparison of benzocaine and lidocaine.
Baskin, SI; Gold, MB; Martin, DG; Watson, CE; Woodard, CL,
)
1.07
"Benzocaine has been labeled a notorious sensitizer. "( A 10-year retrospective study on benzocaine allergy in the United Kingdom.
Shaw, S; Sidhu, SK; Wilkinson, JD, 1999
)
2.03

Actions

Benzocaine is a frequent cause of iatrogenic methemoglobinemia. It failed to produce phototoxic reactions in normal volunteers.

ExcerptReferenceRelevance
"Benzocaine is a frequent cause of iatrogenic methemoglobinemia."( Topical Benzocaine and Methemoglobinemia.
Afeld, JL; Cumpston, KL; Hieger, MA; Wills, BK,
)
1.29
"Benzocaine failed to produce phototoxic reactions in normal volunteers."( Photocontact allergy to benzocaine.
Allen, H; Kaidbey, KH, 1981
)
1.29

Treatment

ExcerptReferenceRelevance
"Benzocaine treatment for 2 or 3 days resulted in 57% and 67% inhibition of liver microsomal aniline 4-hydroxylase and ethylmorphine N-demethylase activities, respectively."( In vivo effects of the anesthetic, benzocaine, on liver microsomal cytochrome P450 and mixed-function oxidase activities of gilthead seabream (Sparus aurata).
Arinç, E; Sen, A, 1994
)
1.29

Toxicity

Among 198 reported adverse events of all types associated with benzocaine, 132 cases (66.5%) were reported. From 818 439 adverse event reports received by the US Food and Drug Administration from November 1997 through March 2002, we extracted every report for use of a benzocane product.

ExcerptReferenceRelevance
"From 818 439 adverse event reports received by the US Food and Drug Administration from November 1997 through March 2002, we extracted every report for use of a benzocaine product."( Reported adverse event cases of methemoglobinemia associated with benzocaine products.
Cohen, MR; Moore, TJ; Walsh, CS, 2004
)
0.76
"Among 198 reported adverse events of all types associated with benzocaine, 132 cases (66."( Reported adverse event cases of methemoglobinemia associated with benzocaine products.
Cohen, MR; Moore, TJ; Walsh, CS, 2004
)
0.8
"Data from this study demonstrate that topical anesthetic for facial rejuvenation can be enhanced with laser pretreatment while maintaining safe blood serum levels."( Topical lidocaine enhanced by laser pretreatment: a safe and effective method of analgesia for facial rejuvenation.
Kenkel, J; Oni, G; Rasko, Y, 2013
)
0.39
"A dose-dependent toxic effect of Auralgan was noted on cultured cells."( Assessment of ototoxicity of intratympanic administration of Auralgan in a chinchilla animal model.
Bezdjian, A; Daniel, SJ; Mujica-Mota, MA; Salehi, P; Schermbrucker, J, 2015
)
0.42
" Due to the lack of appreciable benefits and the presence of notable adverse effects, using vapocoolants or Cetacaine for this tail biopsy procedure in laboratory mice is unadvisable and we encourage the removal of these agents from institutional tail biopsy guidelines."( Adverse effects of vapocoolant and topical anesthesia for tail biopsy of preweanling mice.
Braden, GC; Brice, AK; Hankenson, FC, 2015
)
0.42

Pharmacokinetics

ExcerptReferenceRelevance
" Individual fish were exposed to benzocaine in a recirculating system for 4 h and pharmacokinetic parameters were estimated in a unique manner from the concentration of benzocaine in the bath water vs."( Effect of temperature on the pharmacokinetics of benzocaine in rainbow trout (Oncorhynchus mykiss) after bath exposures.
Gingerich, WH; Meinertz, JR; Stehly, GR, 1998
)
0.84

Bioavailability

ExcerptReferenceRelevance
"The choice of vehicle for patch test materials is important for the bioavailability and stability of the allergens."( Aspects of pharmaceutical and chemical standardization of patch test materials.
Hansen, J; Kreilgård, B, 1989
)
0.28
"When topical controlled delivery of ophthalmic drugs is realised via erodible inserts, drug bioavailability is maximised, if release is controlled exclusively by insert erosion, since parallel mechanisms which increase the release rate, also increases the dose fraction cleared from the precorneal area by tear fluid draining."( A study of release mechanisms of different ophthalmic drugs from erodible ocular inserts based on poly(ethylene oxide).
Di Colo, G; Zambito, Y, 2002
)
0.31
" Overall, our research provides an elegant opportunity for developing effective drug carriers with stable network toward enhancing and/or controlling bioavailability and extending shelf-life of drug molecules using GRAS excipients, food polysaccharides, that are inexpensive and non-toxic."( Organized polysaccharide fibers as stable drug carriers.
Campanella, OH; Gill, KL; Janaswamy, S; Pinal, R, 2013
)
0.39
"Understanding the phase behavior of an active pharmaceutical ingredient in a drug formulation is required to avoid the occurrence of sudden phase changes resulting in decrease of bioavailability in a marketed product."( Benzocaine polymorphism: pressure-temperature phase diagram involving forms II and III.
Barrio, M; Céolin, R; Do, B; Gana, I; Rietveld, IB; Tamarit, JL, 2013
)
1.83
"The ATP-binding cassette transporter P-glycoprotein (P-gp) is known to limit both brain penetration and oral bioavailability of many chemotherapy drugs."( A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
Ambudkar, SV; Brimacombe, KR; Chen, L; Gottesman, MM; Guha, R; Hall, MD; Klumpp-Thomas, C; Lee, OW; Lee, TD; Lusvarghi, S; Robey, RW; Shen, M; Tebase, BG, 2019
)
0.51

Dosage Studied

The polymorphs of benzocaine were obtained by means of techniques commonly used for the preparation of various pharmaceutical dosage forms. Variation in blood radioactivity following administration of the same concentration of 3H-benzocaine in the same dosage form in male and female rats is reported.

ExcerptRelevanceReference
"A colorimetric procedure for benzocaine and a number of its dosage forms was developed; it offers improvement in ease, speed, and sensitivity over the official method."( Colorimetric assay of benzocaine and some dosage forms.
Bruemmer, GA; Shelton, D; Tan, HS, 1977
)
0.86
" Variation in blood radioactivity following administration of the same concentration of 3H-benzocaine in the same dosage form in male and female rats is reported."( Absorption and distribution of radioactivity from suppositories containing 3H-benzocaine in rats.
Ayres, JW; Kuhl, L; Laskar, PA; Lock, A; Lorskulsint, D, 1976
)
0.7
" A dose-response relationship between benzocaine and MHb was investigated."( Topical anesthetic-induced methemoglobinemia in sheep: a comparison of benzocaine and lidocaine.
Guertler, AT; Lagutchik, MS; Martin, DG, 1992
)
0.79
"A simple and rapid spectrophotometric procedure has been developed for the determination of four local anaesthetics containing a free primary amine moiety and of procainamide hydrochloride as the drug substances and in dosage forms."( Use of 7,7,8,8-tetracyanoquinodimethane for spectrophotometric determination of certain local anaesthetics and procainamide hydrochloride.
Hassan, HY; Hussein, SA; Mohamed, AM; Mohamed, HA, 1991
)
0.28
" Hence, the parallel shift produced by benzocaine on the dose-response (fraction of blocked Vmax) curves of lidocaine, strongly suggests that both drugs competed for the same receptor site."( Interaction of lidocaine and benzocaine in depressing Vmax of ventricular action potentials.
Chapula, JS, 1985
)
0.83
" Our observations thus support the conclusions of other workers who used mixtures of two local anesthetics to show that the dose-response behavior does not fit single-site behavior, but requires at least two distinct sites."( Isochannels and blocking modes of voltage-dependent sodium channels.
Guo, X; Heiny, J; Moczydlowski, E; Uehara, A, 1986
)
0.27
" The dose-response curves for each drug suggest that QX 752 and benzocaine each act on a single class of binding sites."( Local anesthetics QX 572 and benzocaine act at separate sites on the batrachotoxin-activated sodium channel.
Ehrenstein, G; Huang, LM, 1981
)
0.79
" Eighty-eight patients entered the between-patient study and each completed a diary card covering symptoms experienced and dosage used for each of the two drugs."( Two lozenges containing benzocaine assessed in the relief of sore throat.
Huddlestone, L; Kagan, G; Wolstencroft, P, 1982
)
0.57
"Comparing dose-response curves (DRCs) of a compound A in the absence and presence of a fixed dose of an antagonist B is standard in pharmacology and toxicology."( Calculating slope and ED50 of additive dose-response curves, and application of these tabulated parameter values.
Pancheva, SN; Pöch, G, 1995
)
0.29
" Venous blood for methemoglobin analysis was collected 20, 40, and 60 minutes after benzocaine dosing and analyzed using a co-oximeter."( A prospective evaluation of benzocaine-associated methemoglobinemia in human beings.
Guertler, AT; Pearce, WA, 1994
)
0.81
" Dose-response curves indicate that only one molecule of benzocaine is required to bind with one BTX-modified Na+ channel at -70 mV, whereas approximately two molecules are needed at +50 mV."( Binding of benzocaine in batrachotoxin-modified Na+ channels. State-dependent interactions.
Wang, GK; Wang, SY, 1994
)
0.92
" The dose-response of BAB administered epidurally and intrathecally as a solution was studied in rats to define the local anesthetic properties in an established animal model."( Epidural and intrathecal n-butyl-p-aminobenzoate solution in the rat. Comparison with bupivacaine.
Breimer, DD; Grouls, RJ; Hellebrekers, LJ; Korsten, HH; Meert, TF, 1997
)
0.3
" The dose-response relation was determined and median effective dose values were calculated."( Epidural and intrathecal n-butyl-p-aminobenzoate solution in the rat. Comparison with bupivacaine.
Breimer, DD; Grouls, RJ; Hellebrekers, LJ; Korsten, HH; Meert, TF, 1997
)
0.3
" They also should follow new recommended dosing guidelines for prilocaine and be aware of symptoms of this adverse reaction."( When patients become cyanotic: acquired methemoglobinemia.
Lloyd, LM; Wilburn-Goo, D, 1999
)
0.3
" There were no significant differences between the two groups with respect to ease of intubation, procedure performance, procedure duration, and dosing of midazolam or meperidine."( Topical pharyngeal anesthesia does not improve upper gastrointestinal endoscopy in conscious sedated patients.
Davis, DE; Jones, MP; Kubik, CM, 1999
)
0.3
" Microscopic studies of the formulations revealed that the coacervates maintained their integrity in the formulation during the preparation and storage of the dosage form."( Use of gelatin-acacia coacervate containing benzocaine in topical formulations.
Dash, AK; Ichwan, AM; Karimi, M, 1999
)
0.56
" The sensitizing capacity of known allergens was quantified by dose-response modeling."( A quantitative method for assessing the sensitizing potency of low molecular weight chemicals using a local lymph node assay: employment of a regression method that includes determination of the uncertainty margins.
de Jong, WH; Slob, W; van Loveren, H; van Och, FM; Vandebriel, RJ, 2000
)
0.31
" Mean and median ingested dosage were 86."( Multi-center retrospective evaluation of oral benzocaine exposure in children.
Gorman, SE; Revolinski, DH; Spiller, HA; Weber, JA; Winter, ML, 2000
)
0.57
"A new HPLC-RP method has been developed and validated for the simultaneous determination of benzocaine, two preservatives (propylparaben (nipasol) and benzyl alcohol) and degradation products of benzocaine in a semisolid pharmaceutical dosage form (benzocaine gel)."( A new validated method for the simultaneous determination of benzocaine, propylparaben and benzyl alcohol in a bioadhesive gel by HPLC.
García-Montoya, E; Miñarro, M; Orriols, A; Pérez-Lozano, P; Suñé-Negre, JM; Ticó, JR, 2005
)
0.79
"This pilot study evaluated subject compliance with a proposed OTC label with improved dosing directions for self-application of a 20% benzocaine gel for toothache pain, and assessed the methodology for evaluating efficacy in a future pivotal study of benzocaine gel."( A study of benzocaine gel dosing for toothache.
DeRossi, SS; Hersh, EV; Secreto, SA; Stoopler, ET, 2005
)
0.92
" Before self-applying 20% benzocaine gel or placebo, patients read a label containing new dosing directions, including a picture of how much product to apply to their tooth and the surrounding gingival tissues."( A study of benzocaine gel dosing for toothache.
DeRossi, SS; Hersh, EV; Secreto, SA; Stoopler, ET, 2005
)
1.02
"The improved dosing directions resulted in a high percentage of subjects self-applying an appropriate amount of benzocaine gel or matching placebo."( A study of benzocaine gel dosing for toothache.
DeRossi, SS; Hersh, EV; Secreto, SA; Stoopler, ET, 2005
)
0.93
"5 to 5 g/L) have been recommended, but few reports describe dose-response testing, the time to loss of consciousness, or the reliability of euthanasia."( Evaluation and refinement of euthanasia methods for Xenopus laevis.
Green, SL; McClure, DE; Torreilles, SL, 2009
)
0.35
"In a reference-controlled double-blind trial in patients with acute pharyngitis the effects of a newly developed lozenge containing 8 mg of benzocaine (p-aminobenzoic acid ethyl ester, CAS 94-09-7) were compared with those of an identically dosed commercial pastille."( Double-blind comparison of two types of benzocaine lozenges for the treatment of acute pharyngitis.
Busch, R; Graubaum, HJ; Grünwald, J; Schmidt, M, 2010
)
0.83
" We measured characteristic sedation and recovery times in response to benzocaine, and used them to devise an intermittent dosing regimen consisting of 14."( A Dynamic Anesthesia System for Long-Term Imaging in Adult Zebrafish.
Kwon, RY; Patil, K; Sanders, GE; Watson, CJ; Wynd, BM, 2017
)
0.69
" Flunixin meglumine at the 25-mg/kg dose provided analgesic relief at the latest time point during etomidate dosage and at all time points during benzocaine dosage, but further characterization is warranted regarding long-term or repeated analgesic administration."( Comparison of Etomidate, Benzocaine, and MS222 Anesthesia with and without Subsequent Flunixin Meglumine Analgesia in African Clawed Frogs (
Carroll, GL; Elliott, JJ; Jeffery, ND; Smith, BD; Taylor, MC; Vail, KJ; Vemulapalli, TH, 2018
)
0.98
" The polymorphs of benzocaine were obtained by means of techniques commonly used for the preparation of various pharmaceutical dosage forms: ball milling, micro milling, and cryogenic grinding, which allowed for the appearance or preservation of form III, the initial conformation of benzocaine."( The Analysis of the Physicochemical Properties of Benzocaine Polymorphs.
Cielecka-Piontek, J; Krause, A; Miklaszewski, A; Mroczkowka, M; Paczkowska, M; Wiergowska, G; Zalewski, P, 2018
)
1.06
" Methemoglobin and oxygen saturation levels did not change compared with baseline after dosing with either treatment."( A Proof-of-concept Study Using Quantitative Sensory Threshold Analysis to Compare Two Intraoral Topical Anesthetics.
Cooper, SA; Doyle, G; Farrar, JT; Giannakopoulos, H; Hersh, EV; Hutcheson, MC; Lesavoy, B; Mousavian, M; Secreto, S; Wang, P; Wang, S, 2019
)
0.51
" This study opens perspectives for using nanoformulations prepared with BENZ in aquaculture, allowing reduction of dosage as well as promoting more effective anesthesia and improved interaction with the mucoadhesive system of fish."( Potential of mucoadhesive nanocapsules in drug release and toxicology in zebrafish.
Barros, ALB; Belo, MAA; Borra, RC; Castro, TFD; Charlie-Silva, I; Corrêa Junior, JD; de Melo, NFS; de Menezes, GB; Eto, SF; Feitosa, NM; Fernandes, DC; Fraceto, LF; Fukushima, HCS; Gomes, JMM; Hoyos, DCM; Mattioli, CC; Pierezan, F; Silva, JO, 2020
)
0.56
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (4)

RoleDescription
topical anaestheticA local anesthetic that is used to numb the surface of a body part.
antipruritic drugA drug, usually applied topically, that relieves pruritus (itching).
allergenA chemical compound, or part thereof, which causes the onset of an allergic reaction by interacting with any of the molecular pathways involved in an allergy.
sensitiserA chemical compound that causes a substantial proportion of exposed people or animals to develop an allergic reaction in normal tissue after repeated exposure to the compound.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (2)

ClassDescription
benzoate esterEsters of benzoic acid or substituted benzoic acids.
substituted aniline
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Pathways (1)

PathwayProteinsCompounds
Benzocaine Action Pathway3111

Protein Targets (48)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
glp-1 receptor, partialHomo sapiens (human)Potency14.12540.01846.806014.1254AID624172
RAR-related orphan receptor gammaMus musculus (house mouse)Potency5.37030.006038.004119,952.5996AID1159521; AID1159523
ATAD5 protein, partialHomo sapiens (human)Potency13.14610.004110.890331.5287AID504466; AID504467
USP1 protein, partialHomo sapiens (human)Potency39.81070.031637.5844354.8130AID504865
AR proteinHomo sapiens (human)Potency0.00070.000221.22318,912.5098AID743042
nuclear receptor subfamily 1, group I, member 3Homo sapiens (human)Potency37.93500.001022.650876.6163AID1224838; AID1224893
retinoic acid nuclear receptor alpha variant 1Homo sapiens (human)Potency35.33970.003041.611522,387.1992AID1159552; AID1159553; AID1159555
estrogen-related nuclear receptor alphaHomo sapiens (human)Potency20.69720.001530.607315,848.9004AID1224848; AID1224849; AID1259403
estrogen nuclear receptor alphaHomo sapiens (human)Potency32.09070.000229.305416,493.5996AID1259244; AID743069; AID743075; AID743078; AID743079; AID743080; AID743091
GVesicular stomatitis virusPotency27.54040.01238.964839.8107AID1645842
peroxisome proliferator-activated receptor deltaHomo sapiens (human)Potency54.94100.001024.504861.6448AID743212
aryl hydrocarbon receptorHomo sapiens (human)Potency40.66720.000723.06741,258.9301AID743085; AID743122
cytochrome P450, family 19, subfamily A, polypeptide 1, isoform CRA_aHomo sapiens (human)Potency33.61370.001723.839378.1014AID743083
thyroid stimulating hormone receptorHomo sapiens (human)Potency18.83360.001628.015177.1139AID1259385
nuclear factor erythroid 2-related factor 2 isoform 1Homo sapiens (human)Potency40.85620.000627.21521,122.0200AID743219
nuclear receptor ROR-gamma isoform 1Mus musculus (house mouse)Potency7.07950.00798.23321,122.0200AID2551
gemininHomo sapiens (human)Potency0.40790.004611.374133.4983AID624296; AID624297
cytochrome P450 3A4 isoform 1Homo sapiens (human)Potency27.82980.031610.279239.8107AID884; AID885
lamin isoform A-delta10Homo sapiens (human)Potency7.94330.891312.067628.1838AID1487
Gamma-aminobutyric acid receptor subunit piRattus norvegicus (Norway rat)Potency27.82981.000012.224831.6228AID885
Voltage-dependent calcium channel gamma-2 subunitMus musculus (house mouse)Potency33.93390.001557.789015,848.9004AID1259244
Interferon betaHomo sapiens (human)Potency27.54040.00339.158239.8107AID1645842
HLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)Potency27.54040.01238.964839.8107AID1645842
Gamma-aminobutyric acid receptor subunit beta-1Rattus norvegicus (Norway rat)Potency27.82981.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit deltaRattus norvegicus (Norway rat)Potency27.82981.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit gamma-2Rattus norvegicus (Norway rat)Potency27.82981.000012.224831.6228AID885
Glutamate receptor 2Rattus norvegicus (Norway rat)Potency33.93390.001551.739315,848.9004AID1259244
Gamma-aminobutyric acid receptor subunit alpha-5Rattus norvegicus (Norway rat)Potency27.82981.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit alpha-3Rattus norvegicus (Norway rat)Potency27.82981.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit gamma-1Rattus norvegicus (Norway rat)Potency27.82981.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit alpha-2Rattus norvegicus (Norway rat)Potency27.82981.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit alpha-4Rattus norvegicus (Norway rat)Potency27.82981.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit gamma-3Rattus norvegicus (Norway rat)Potency27.82981.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit alpha-6Rattus norvegicus (Norway rat)Potency27.82981.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit alpha-1Rattus norvegicus (Norway rat)Potency27.82981.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit beta-3Rattus norvegicus (Norway rat)Potency27.82981.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit beta-2Rattus norvegicus (Norway rat)Potency27.82981.000012.224831.6228AID885
TAR DNA-binding protein 43Homo sapiens (human)Potency35.48131.778316.208135.4813AID652104
GABA theta subunitRattus norvegicus (Norway rat)Potency27.82981.000012.224831.6228AID885
Inositol hexakisphosphate kinase 1Homo sapiens (human)Potency27.54040.01238.964839.8107AID1645842
ATPase family AAA domain-containing protein 5Homo sapiens (human)Potency43.27710.011917.942071.5630AID651632
Ataxin-2Homo sapiens (human)Potency43.27710.011912.222168.7989AID651632
Gamma-aminobutyric acid receptor subunit epsilonRattus norvegicus (Norway rat)Potency27.82981.000012.224831.6228AID885
cytochrome P450 2C9, partialHomo sapiens (human)Potency27.54040.01238.964839.8107AID1645842
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
ATP-binding cassette sub-family C member 3Homo sapiens (human)IC50 (µMol)133.00000.63154.45319.3000AID1473740
Multidrug resistance-associated protein 4Homo sapiens (human)IC50 (µMol)133.00000.20005.677410.0000AID1473741
Bile salt export pumpHomo sapiens (human)IC50 (µMol)566.50000.11007.190310.0000AID1449628; AID1473738
Canalicular multispecific organic anion transporter 1Homo sapiens (human)IC50 (µMol)133.00002.41006.343310.0000AID1473739
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (121)

Processvia Protein(s)Taxonomy
xenobiotic metabolic processATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
bile acid and bile salt transportATP-binding cassette sub-family C member 3Homo sapiens (human)
glucuronoside transportATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transportATP-binding cassette sub-family C member 3Homo sapiens (human)
transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
leukotriene transportATP-binding cassette sub-family C member 3Homo sapiens (human)
monoatomic anion transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
transport across blood-brain barrierATP-binding cassette sub-family C member 3Homo sapiens (human)
prostaglandin secretionMultidrug resistance-associated protein 4Homo sapiens (human)
cilium assemblyMultidrug resistance-associated protein 4Homo sapiens (human)
platelet degranulationMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic metabolic processMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
bile acid and bile salt transportMultidrug resistance-associated protein 4Homo sapiens (human)
prostaglandin transportMultidrug resistance-associated protein 4Homo sapiens (human)
urate transportMultidrug resistance-associated protein 4Homo sapiens (human)
glutathione transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
cAMP transportMultidrug resistance-associated protein 4Homo sapiens (human)
leukotriene transportMultidrug resistance-associated protein 4Homo sapiens (human)
monoatomic anion transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
export across plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
transport across blood-brain barrierMultidrug resistance-associated protein 4Homo sapiens (human)
guanine nucleotide transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
fatty acid metabolic processBile salt export pumpHomo sapiens (human)
bile acid biosynthetic processBile salt export pumpHomo sapiens (human)
xenobiotic metabolic processBile salt export pumpHomo sapiens (human)
xenobiotic transmembrane transportBile salt export pumpHomo sapiens (human)
response to oxidative stressBile salt export pumpHomo sapiens (human)
bile acid metabolic processBile salt export pumpHomo sapiens (human)
response to organic cyclic compoundBile salt export pumpHomo sapiens (human)
bile acid and bile salt transportBile salt export pumpHomo sapiens (human)
canalicular bile acid transportBile salt export pumpHomo sapiens (human)
protein ubiquitinationBile salt export pumpHomo sapiens (human)
regulation of fatty acid beta-oxidationBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transportBile salt export pumpHomo sapiens (human)
bile acid signaling pathwayBile salt export pumpHomo sapiens (human)
cholesterol homeostasisBile salt export pumpHomo sapiens (human)
response to estrogenBile salt export pumpHomo sapiens (human)
response to ethanolBile salt export pumpHomo sapiens (human)
xenobiotic export from cellBile salt export pumpHomo sapiens (human)
lipid homeostasisBile salt export pumpHomo sapiens (human)
phospholipid homeostasisBile salt export pumpHomo sapiens (human)
positive regulation of bile acid secretionBile salt export pumpHomo sapiens (human)
regulation of bile acid metabolic processBile salt export pumpHomo sapiens (human)
transmembrane transportBile salt export pumpHomo sapiens (human)
cell surface receptor signaling pathway via JAK-STATInterferon betaHomo sapiens (human)
response to exogenous dsRNAInterferon betaHomo sapiens (human)
B cell activation involved in immune responseInterferon betaHomo sapiens (human)
cell surface receptor signaling pathwayInterferon betaHomo sapiens (human)
cell surface receptor signaling pathway via JAK-STATInterferon betaHomo sapiens (human)
response to virusInterferon betaHomo sapiens (human)
positive regulation of autophagyInterferon betaHomo sapiens (human)
cytokine-mediated signaling pathwayInterferon betaHomo sapiens (human)
natural killer cell activationInterferon betaHomo sapiens (human)
positive regulation of peptidyl-serine phosphorylation of STAT proteinInterferon betaHomo sapiens (human)
cellular response to interferon-betaInterferon betaHomo sapiens (human)
B cell proliferationInterferon betaHomo sapiens (human)
negative regulation of viral genome replicationInterferon betaHomo sapiens (human)
innate immune responseInterferon betaHomo sapiens (human)
positive regulation of innate immune responseInterferon betaHomo sapiens (human)
regulation of MHC class I biosynthetic processInterferon betaHomo sapiens (human)
negative regulation of T cell differentiationInterferon betaHomo sapiens (human)
positive regulation of transcription by RNA polymerase IIInterferon betaHomo sapiens (human)
defense response to virusInterferon betaHomo sapiens (human)
type I interferon-mediated signaling pathwayInterferon betaHomo sapiens (human)
neuron cellular homeostasisInterferon betaHomo sapiens (human)
cellular response to exogenous dsRNAInterferon betaHomo sapiens (human)
cellular response to virusInterferon betaHomo sapiens (human)
negative regulation of Lewy body formationInterferon betaHomo sapiens (human)
negative regulation of T-helper 2 cell cytokine productionInterferon betaHomo sapiens (human)
positive regulation of apoptotic signaling pathwayInterferon betaHomo sapiens (human)
response to exogenous dsRNAInterferon betaHomo sapiens (human)
B cell differentiationInterferon betaHomo sapiens (human)
natural killer cell activation involved in immune responseInterferon betaHomo sapiens (human)
adaptive immune responseInterferon betaHomo sapiens (human)
T cell activation involved in immune responseInterferon betaHomo sapiens (human)
humoral immune responseInterferon betaHomo sapiens (human)
positive regulation of T cell mediated cytotoxicityHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
adaptive immune responseHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
antigen processing and presentation of endogenous peptide antigen via MHC class I via ER pathway, TAP-independentHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
regulation of T cell anergyHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
defense responseHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
immune responseHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
detection of bacteriumHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
regulation of interleukin-12 productionHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
regulation of interleukin-6 productionHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
protection from natural killer cell mediated cytotoxicityHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
innate immune responseHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
regulation of dendritic cell differentiationHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
antigen processing and presentation of endogenous peptide antigen via MHC class IbHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
negative regulation of protein phosphorylationTAR DNA-binding protein 43Homo sapiens (human)
mRNA processingTAR DNA-binding protein 43Homo sapiens (human)
RNA splicingTAR DNA-binding protein 43Homo sapiens (human)
negative regulation of gene expressionTAR DNA-binding protein 43Homo sapiens (human)
regulation of protein stabilityTAR DNA-binding protein 43Homo sapiens (human)
positive regulation of insulin secretionTAR DNA-binding protein 43Homo sapiens (human)
response to endoplasmic reticulum stressTAR DNA-binding protein 43Homo sapiens (human)
positive regulation of protein import into nucleusTAR DNA-binding protein 43Homo sapiens (human)
regulation of circadian rhythmTAR DNA-binding protein 43Homo sapiens (human)
regulation of apoptotic processTAR DNA-binding protein 43Homo sapiens (human)
negative regulation by host of viral transcriptionTAR DNA-binding protein 43Homo sapiens (human)
rhythmic processTAR DNA-binding protein 43Homo sapiens (human)
regulation of cell cycleTAR DNA-binding protein 43Homo sapiens (human)
3'-UTR-mediated mRNA destabilizationTAR DNA-binding protein 43Homo sapiens (human)
3'-UTR-mediated mRNA stabilizationTAR DNA-binding protein 43Homo sapiens (human)
nuclear inner membrane organizationTAR DNA-binding protein 43Homo sapiens (human)
amyloid fibril formationTAR DNA-binding protein 43Homo sapiens (human)
regulation of gene expressionTAR DNA-binding protein 43Homo sapiens (human)
inositol phosphate metabolic processInositol hexakisphosphate kinase 1Homo sapiens (human)
phosphatidylinositol phosphate biosynthetic processInositol hexakisphosphate kinase 1Homo sapiens (human)
negative regulation of cold-induced thermogenesisInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol phosphate biosynthetic processInositol hexakisphosphate kinase 1Homo sapiens (human)
xenobiotic metabolic processCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
negative regulation of gene expressionCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bile acid and bile salt transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bilirubin transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
heme catabolic processCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic export from cellCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transepithelial transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
leukotriene transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
monoatomic anion transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transport across blood-brain barrierCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transport across blood-brain barrierCanalicular multispecific organic anion transporter 1Homo sapiens (human)
cell population proliferationATPase family AAA domain-containing protein 5Homo sapiens (human)
positive regulation of B cell proliferationATPase family AAA domain-containing protein 5Homo sapiens (human)
nuclear DNA replicationATPase family AAA domain-containing protein 5Homo sapiens (human)
signal transduction in response to DNA damageATPase family AAA domain-containing protein 5Homo sapiens (human)
intrinsic apoptotic signaling pathway in response to DNA damage by p53 class mediatorATPase family AAA domain-containing protein 5Homo sapiens (human)
isotype switchingATPase family AAA domain-containing protein 5Homo sapiens (human)
positive regulation of DNA replicationATPase family AAA domain-containing protein 5Homo sapiens (human)
positive regulation of isotype switching to IgG isotypesATPase family AAA domain-containing protein 5Homo sapiens (human)
DNA clamp unloadingATPase family AAA domain-containing protein 5Homo sapiens (human)
regulation of mitotic cell cycle phase transitionATPase family AAA domain-containing protein 5Homo sapiens (human)
negative regulation of intrinsic apoptotic signaling pathway in response to DNA damage by p53 class mediatorATPase family AAA domain-containing protein 5Homo sapiens (human)
positive regulation of cell cycle G2/M phase transitionATPase family AAA domain-containing protein 5Homo sapiens (human)
negative regulation of receptor internalizationAtaxin-2Homo sapiens (human)
regulation of translationAtaxin-2Homo sapiens (human)
RNA metabolic processAtaxin-2Homo sapiens (human)
P-body assemblyAtaxin-2Homo sapiens (human)
stress granule assemblyAtaxin-2Homo sapiens (human)
RNA transportAtaxin-2Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (52)

Processvia Protein(s)Taxonomy
ATP bindingATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type xenobiotic transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
glucuronoside transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type bile acid transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATP hydrolysis activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATPase-coupled transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
icosanoid transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
guanine nucleotide transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
protein bindingMultidrug resistance-associated protein 4Homo sapiens (human)
ATP bindingMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type xenobiotic transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
prostaglandin transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
urate transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
purine nucleotide transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type bile acid transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
efflux transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
15-hydroxyprostaglandin dehydrogenase (NAD+) activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATP hydrolysis activityMultidrug resistance-associated protein 4Homo sapiens (human)
glutathione transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATPase-coupled transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
protein bindingBile salt export pumpHomo sapiens (human)
ATP bindingBile salt export pumpHomo sapiens (human)
ABC-type xenobiotic transporter activityBile salt export pumpHomo sapiens (human)
bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
canalicular bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transporter activityBile salt export pumpHomo sapiens (human)
ABC-type bile acid transporter activityBile salt export pumpHomo sapiens (human)
ATP hydrolysis activityBile salt export pumpHomo sapiens (human)
cytokine activityInterferon betaHomo sapiens (human)
cytokine receptor bindingInterferon betaHomo sapiens (human)
type I interferon receptor bindingInterferon betaHomo sapiens (human)
protein bindingInterferon betaHomo sapiens (human)
chloramphenicol O-acetyltransferase activityInterferon betaHomo sapiens (human)
TAP bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
signaling receptor bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
protein bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
peptide antigen bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
TAP bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
protein-folding chaperone bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
RNA polymerase II cis-regulatory region sequence-specific DNA bindingTAR DNA-binding protein 43Homo sapiens (human)
DNA bindingTAR DNA-binding protein 43Homo sapiens (human)
double-stranded DNA bindingTAR DNA-binding protein 43Homo sapiens (human)
RNA bindingTAR DNA-binding protein 43Homo sapiens (human)
mRNA 3'-UTR bindingTAR DNA-binding protein 43Homo sapiens (human)
protein bindingTAR DNA-binding protein 43Homo sapiens (human)
lipid bindingTAR DNA-binding protein 43Homo sapiens (human)
identical protein bindingTAR DNA-binding protein 43Homo sapiens (human)
pre-mRNA intronic bindingTAR DNA-binding protein 43Homo sapiens (human)
molecular condensate scaffold activityTAR DNA-binding protein 43Homo sapiens (human)
inositol-1,3,4,5,6-pentakisphosphate kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol hexakisphosphate kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol heptakisphosphate kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol hexakisphosphate 5-kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
protein bindingInositol hexakisphosphate kinase 1Homo sapiens (human)
ATP bindingInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol hexakisphosphate 1-kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol hexakisphosphate 3-kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol 5-diphosphate pentakisphosphate 5-kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol diphosphate tetrakisphosphate kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
protein bindingCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATP bindingCanalicular multispecific organic anion transporter 1Homo sapiens (human)
organic anion transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type xenobiotic transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bilirubin transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATP hydrolysis activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATPase-coupled transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
protein bindingATPase family AAA domain-containing protein 5Homo sapiens (human)
ATP bindingATPase family AAA domain-containing protein 5Homo sapiens (human)
ATP hydrolysis activityATPase family AAA domain-containing protein 5Homo sapiens (human)
DNA clamp unloader activityATPase family AAA domain-containing protein 5Homo sapiens (human)
DNA bindingATPase family AAA domain-containing protein 5Homo sapiens (human)
RNA bindingAtaxin-2Homo sapiens (human)
epidermal growth factor receptor bindingAtaxin-2Homo sapiens (human)
protein bindingAtaxin-2Homo sapiens (human)
mRNA bindingAtaxin-2Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (43)

Processvia Protein(s)Taxonomy
plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
basal plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
basolateral plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
nucleolusMultidrug resistance-associated protein 4Homo sapiens (human)
Golgi apparatusMultidrug resistance-associated protein 4Homo sapiens (human)
plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
membraneMultidrug resistance-associated protein 4Homo sapiens (human)
basolateral plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
apical plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
platelet dense granule membraneMultidrug resistance-associated protein 4Homo sapiens (human)
external side of apical plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
basolateral plasma membraneBile salt export pumpHomo sapiens (human)
Golgi membraneBile salt export pumpHomo sapiens (human)
endosomeBile salt export pumpHomo sapiens (human)
plasma membraneBile salt export pumpHomo sapiens (human)
cell surfaceBile salt export pumpHomo sapiens (human)
apical plasma membraneBile salt export pumpHomo sapiens (human)
intercellular canaliculusBile salt export pumpHomo sapiens (human)
intracellular canaliculusBile salt export pumpHomo sapiens (human)
recycling endosomeBile salt export pumpHomo sapiens (human)
recycling endosome membraneBile salt export pumpHomo sapiens (human)
extracellular exosomeBile salt export pumpHomo sapiens (human)
membraneBile salt export pumpHomo sapiens (human)
extracellular spaceInterferon betaHomo sapiens (human)
extracellular regionInterferon betaHomo sapiens (human)
Golgi membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
endoplasmic reticulumHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
Golgi apparatusHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
plasma membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
cell surfaceHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
ER to Golgi transport vesicle membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
secretory granule membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
phagocytic vesicle membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
early endosome membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
recycling endosome membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
extracellular exosomeHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
lumenal side of endoplasmic reticulum membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
MHC class I protein complexHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
extracellular spaceHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
external side of plasma membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
plasma membraneGamma-aminobutyric acid receptor subunit gamma-2Rattus norvegicus (Norway rat)
plasma membraneGlutamate receptor 2Rattus norvegicus (Norway rat)
plasma membraneGamma-aminobutyric acid receptor subunit alpha-1Rattus norvegicus (Norway rat)
plasma membraneGamma-aminobutyric acid receptor subunit beta-2Rattus norvegicus (Norway rat)
intracellular non-membrane-bounded organelleTAR DNA-binding protein 43Homo sapiens (human)
nucleusTAR DNA-binding protein 43Homo sapiens (human)
nucleoplasmTAR DNA-binding protein 43Homo sapiens (human)
perichromatin fibrilsTAR DNA-binding protein 43Homo sapiens (human)
mitochondrionTAR DNA-binding protein 43Homo sapiens (human)
cytoplasmic stress granuleTAR DNA-binding protein 43Homo sapiens (human)
nuclear speckTAR DNA-binding protein 43Homo sapiens (human)
interchromatin granuleTAR DNA-binding protein 43Homo sapiens (human)
nucleoplasmTAR DNA-binding protein 43Homo sapiens (human)
chromatinTAR DNA-binding protein 43Homo sapiens (human)
fibrillar centerInositol hexakisphosphate kinase 1Homo sapiens (human)
nucleoplasmInositol hexakisphosphate kinase 1Homo sapiens (human)
cytosolInositol hexakisphosphate kinase 1Homo sapiens (human)
nucleusInositol hexakisphosphate kinase 1Homo sapiens (human)
cytoplasmInositol hexakisphosphate kinase 1Homo sapiens (human)
plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
cell surfaceCanalicular multispecific organic anion transporter 1Homo sapiens (human)
apical plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
intercellular canaliculusCanalicular multispecific organic anion transporter 1Homo sapiens (human)
apical plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
Elg1 RFC-like complexATPase family AAA domain-containing protein 5Homo sapiens (human)
nucleusATPase family AAA domain-containing protein 5Homo sapiens (human)
cytoplasmAtaxin-2Homo sapiens (human)
Golgi apparatusAtaxin-2Homo sapiens (human)
trans-Golgi networkAtaxin-2Homo sapiens (human)
cytosolAtaxin-2Homo sapiens (human)
cytoplasmic stress granuleAtaxin-2Homo sapiens (human)
membraneAtaxin-2Homo sapiens (human)
perinuclear region of cytoplasmAtaxin-2Homo sapiens (human)
ribonucleoprotein complexAtaxin-2Homo sapiens (human)
cytoplasmic stress granuleAtaxin-2Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (75)

Assay IDTitleYearJournalArticle
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID504810Antagonists of the Thyroid Stimulating Hormone Receptor: HTS campaign2010Endocrinology, Jul, Volume: 151, Issue:7
A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
AID504812Inverse Agonists of the Thyroid Stimulating Hormone Receptor: HTS campaign2010Endocrinology, Jul, Volume: 151, Issue:7
A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
AID1745845Primary qHTS for Inhibitors of ATXN expression
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID651635Viability Counterscreen for Primary qHTS for Inhibitors of ATXN expression
AID1347083qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: Viability assay - alamar blue signal for LASV Primary Screen2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347086qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lymphocytic Choriomeningitis Arenaviruses (LCMV): LCMV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347082qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: LASV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347407qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS Pharmaceutical Collection2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID1347096qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for U-2 OS cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347102qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh18 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347095qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB-EBc1 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347092qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for A673 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347089qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for TC32 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347424RapidFire Mass Spectrometry qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1)2019The Journal of biological chemistry, 11-15, Volume: 294, Issue:46
Physiologically relevant orthogonal assays for the discovery of small-molecule modulators of WIP1 phosphatase in high-throughput screens.
AID1347105qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for MG 63 (6-TG R) cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347100qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for LAN-5 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1296008Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening2020SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1
Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening.
AID1347104qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for RD cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347091qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SJ-GBM2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347107qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh30 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347108qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh41 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347101qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-12 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347425Rhodamine-PBP qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1)2019The Journal of biological chemistry, 11-15, Volume: 294, Issue:46
Physiologically relevant orthogonal assays for the discovery of small-molecule modulators of WIP1 phosphatase in high-throughput screens.
AID1347103qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for OHS-50 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347154Primary screen GU AMC qHTS for Zika virus inhibitors2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1347098qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-SH cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347106qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for control Hh wild type fibroblast cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347093qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-MC cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347090qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for DAOY cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347099qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB1643 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347097qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Saos-2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347094qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-37 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1508630Primary qHTS for small molecule stabilizers of the endoplasmic reticulum resident proteome: Secreted ER Calcium Modulated Protein (SERCaMP) assay2021Cell reports, 04-27, Volume: 35, Issue:4
A target-agnostic screen identifies approved drugs to stabilize the endoplasmic reticulum-resident proteome.
AID1449628Inhibition of human BSEP expressed in baculovirus transfected fall armyworm Sf21 cell membranes vesicles assessed as reduction in ATP-dependent [3H]-taurocholate transport into vesicles incubated for 5 mins by Topcount based rapid filtration method2012Drug metabolism and disposition: the biological fate of chemicals, Dec, Volume: 40, Issue:12
Mitigating the inhibition of human bile salt export pump by drugs: opportunities provided by physicochemical property modulation, in silico modeling, and structural modification.
AID450273Lipophilicity, log P of the compound2009Bioorganic & medicinal chemistry, Oct-01, Volume: 17, Issue:19
Ligand-based design and synthesis of novel sodium channel blockers from a combined phenytoin-lidocaine pharmacophore.
AID1768729Lipophilicity, logP of compound by shake flask method2021Bioorganic & medicinal chemistry letters, 10-01, Volume: 49Estimation of the lipophilicity of purine-2,6-dione-based TRPA1 antagonists and PDE4/7 inhibitors with analgesic activity.
AID205267Inhibition of binding of Batrachotoxinin [3H]BTX-B to high affinity sites on voltage dependent sodium channels in a vesicular preparation from guinea pig cerebral cortex1985Journal of medicinal chemistry, Mar, Volume: 28, Issue:3
[3H]Batrachotoxinin A 20 alpha-benzoate binding to voltage-sensitive sodium channels: a rapid and quantitative assay for local anesthetic activity in a variety of drugs.
AID1473739Inhibition of human MRP2 overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1146770Competitive inhibition of Escherichia coli B H2-pteroate synthetase assessed as decrease in H2-pteroate formation using [7-14C]-PABA as substrate treated with enzyme for 10 mins prior to substrate challenge for 40 mins by radioassay method1977Journal of medicinal chemistry, Feb, Volume: 20, Issue:2
P-Aminobenzoic acid derivatives as inhibitors of the cell-free H2-pteroate synthesizing system of Escherichia coli.
AID19262Aqueous solubility2000Bioorganic & medicinal chemistry letters, Jun-05, Volume: 10, Issue:11
Prediction of drug solubility from Monte Carlo simulations.
AID395325Lipophilicity, log P by microemulsion electrokinetic chromatography2009Journal of medicinal chemistry, Mar-26, Volume: 52, Issue:6
Relationship between brain tissue partitioning and microemulsion retention factors of CNS drugs.
AID1473741Inhibition of human MRP4 overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID395328Lipophilicity, log P of the compound2009Journal of medicinal chemistry, Mar-26, Volume: 52, Issue:6
Relationship between brain tissue partitioning and microemulsion retention factors of CNS drugs.
AID346025Binding affinity to beta cyclodextrin2009Bioorganic & medicinal chemistry, Jan-15, Volume: 17, Issue:2
Convenient QSAR model for predicting the complexation of structurally diverse compounds with beta-cyclodextrins.
AID450269Displacement of [3H]-BTX-B from neuronal voltage-gated sodium channel in rat cerebral cortex synaptoneurosomes2009Bioorganic & medicinal chemistry, Oct-01, Volume: 17, Issue:19
Ligand-based design and synthesis of novel sodium channel blockers from a combined phenytoin-lidocaine pharmacophore.
AID227700Anticonvulsant activity2003Bioorganic & medicinal chemistry letters, Aug-18, Volume: 13, Issue:16
Topological virtual screening: a way to find new anticonvulsant drugs from chemical diversity.
AID1146772Dissociation constant, pKa of the compound1977Journal of medicinal chemistry, Feb, Volume: 20, Issue:2
P-Aminobenzoic acid derivatives as inhibitors of the cell-free H2-pteroate synthesizing system of Escherichia coli.
AID680306TP_TRANSPORTER: increase in Calcein-AM intracellular accumulation (Calcein-AM: 0.5 uM, Benzocaine: 20 uM) in MDR1-expressing NIH-3T3 cells2004Biochemical and biophysical research communications, Mar-19, Volume: 315, Issue:4
Distinct groups of multidrug resistance modulating agents are distinguished by competition of P-glycoprotein-specific antibodies.
AID1473740Inhibition of human MRP3 overexpressed in Sf9 insect cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 10 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID977602Inhibition of sodium fluorescein uptake in OATP1B3-transfected CHO cells at an equimolar substrate-inhibitor concentration of 10 uM2013Molecular pharmacology, Jun, Volume: 83, Issue:6
Structure-based identification of OATP1B1/3 inhibitors.
AID977599Inhibition of sodium fluorescein uptake in OATP1B1-transfected CHO cells at an equimolar substrate-inhibitor concentration of 10 uM2013Molecular pharmacology, Jun, Volume: 83, Issue:6
Structure-based identification of OATP1B1/3 inhibitors.
AID515780Intrinsic solubility of the compound in water2010Bioorganic & medicinal chemistry, Oct-01, Volume: 18, Issue:19
QSAR-based solubility model for drug-like compounds.
AID1768730Relative lipophilicity of the compound in methanol assessed as retardation factor by reversed-phase TLC analysis2021Bioorganic & medicinal chemistry letters, 10-01, Volume: 49Estimation of the lipophilicity of purine-2,6-dione-based TRPA1 antagonists and PDE4/7 inhibitors with analgesic activity.
AID1061889Displacement of [3H]BTX-B from neuronal voltage-gated sodium channel in rat cerebral cortex synaptoneurosomes after 60 mins by scintillation counting2014Bioorganic & medicinal chemistry, Jan-01, Volume: 22, Issue:1
A highly predictive 3D-QSAR model for binding to the voltage-gated sodium channel: design of potent new ligands.
AID205268Inhibition of binding of Batrachotoxinin [3H]BTX-B to high affinity sites on voltage dependent sodium channels in a vesicular preparation from guinea pig cerebral cortex at 10 uM1985Journal of medicinal chemistry, Mar, Volume: 28, Issue:3
[3H]Batrachotoxinin A 20 alpha-benzoate binding to voltage-sensitive sodium channels: a rapid and quantitative assay for local anesthetic activity in a variety of drugs.
AID384956Dissociation constant, pKa of the compound2008Journal of medicinal chemistry, May-22, Volume: 51, Issue:10
Molecular characteristics for solid-state limited solubility.
AID1473738Inhibition of human BSEP overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-taurocholate in presence of ATP measured after 15 to 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID384955Intrinsic aqueous solubility at pH 10 by shake-flask method2008Journal of medicinal chemistry, May-22, Volume: 51, Issue:10
Molecular characteristics for solid-state limited solubility.
AID205269Inhibition of binding of Batrachotoxinin [3H]BTX-B to high-affinity sites on voltage-dependent sodium channels in a vesicular preparation from guinea pig cerebral cortex at 100 uM1985Journal of medicinal chemistry, Mar, Volume: 28, Issue:3
[3H]Batrachotoxinin A 20 alpha-benzoate binding to voltage-sensitive sodium channels: a rapid and quantitative assay for local anesthetic activity in a variety of drugs.
AID504749qHTS profiling for inhibitors of Plasmodium falciparum proliferation2011Science (New York, N.Y.), Aug-05, Volume: 333, Issue:6043
Chemical genomic profiling for antimalarial therapies, response signatures, and molecular targets.
AID1346986P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1346987P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID588519A screen for compounds that inhibit viral RNA polymerase binding and polymerization activities2011Antiviral research, Sep, Volume: 91, Issue:3
High-throughput screening identification of poliovirus RNA-dependent RNA polymerase inhibitors.
AID540299A screen for compounds that inhibit the MenB enzyme of Mycobacterium tuberculosis2010Bioorganic & medicinal chemistry letters, Nov-01, Volume: 20, Issue:21
Synthesis and SAR studies of 1,4-benzoxazine MenB inhibitors: novel antibacterial agents against Mycobacterium tuberculosis.
AID1159607Screen for inhibitors of RMI FANCM (MM2) intereaction2016Journal of biomolecular screening, Jul, Volume: 21, Issue:6
A High-Throughput Screening Strategy to Identify Protein-Protein Interaction Inhibitors That Block the Fanconi Anemia DNA Repair Pathway.
AID1159550Human Phosphogluconate dehydrogenase (6PGD) Inhibitor Screening2015Nature cell biology, Nov, Volume: 17, Issue:11
6-Phosphogluconate dehydrogenase links oxidative PPP, lipogenesis and tumour growth by inhibiting LKB1-AMPK signalling.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (1,112)

TimeframeStudies, This Drug (%)All Drugs %
pre-1990445 (40.02)18.7374
1990's176 (15.83)18.2507
2000's223 (20.05)29.6817
2010's219 (19.69)24.3611
2020's49 (4.41)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 62.69

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index62.69 (24.57)
Research Supply Index7.22 (2.92)
Research Growth Index4.47 (4.65)
Search Engine Demand Index171.70 (26.88)
Search Engine Supply Index3.12 (0.95)

This Compound (62.69)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials132 (10.75%)5.53%
Reviews50 (4.07%)6.00%
Case Studies223 (18.16%)4.05%
Observational1 (0.08%)0.25%
Other822 (66.94%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (61)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
[NCT01149278]800 participants (Actual)Interventional2010-03-31Completed
Effect of Topical Application of Clove Gel Versus Benzocaine Gel on Pain Reduction During Application of Simple Dental Procedures in Children: A Randomized Clinical Trial. [NCT05507359]54 participants (Anticipated)Interventional2023-03-01Not yet recruiting
The Efficiency of Pronase Granules in Gastric Cleaning of Magnetically Controlled Capsule Endoscopy: a Prospective Randomized Controlled Study [NCT05249933]Phase 2/Phase 3290 participants (Anticipated)Interventional2021-02-24Recruiting
Prevention of Scoliosis in Patients With Duchenne Muscular Dystrophy Using Portable Seat Device Devised to Maintain Lumbar Lordosis : 5 Year Follow up Study [NCT03611244]98 participants (Anticipated)Interventional2018-08-07Recruiting
Using Interactive Voice Response To Improve Disease Management and Compliance With Acute Coronary Syndrome Best Practice Guidelines [NCT01151800]1,608 participants (Actual)Interventional2006-01-31Completed
Pain Assessment During Mandibular Nerve Block Injection With the Aid of Dental Vibe Tool in Pediatric Dental Patients: A Randomized Controlled Trial. [NCT03790540]Phase 260 participants (Actual)Interventional2018-12-01Completed
A Multi-centre, Randomized, Placebo-controlled, Double-blind, Parallel-group Study Investigating Safety and Efficacy of a Sore Throat Lozenge in the Symptomatic Treatment of Patients With Acute Pharyngitis [NCT03323528]Phase 4321 participants (Actual)Interventional2017-02-01Completed
Mean Arterial Pressure After Out-of-hospital Cardiac Arrest: the METAPHORE Randomized Trial [NCT05486884]1,608 participants (Anticipated)Interventional2023-07-01Not yet recruiting
A Double Masked, Randomised, 3-way Cross-over, Single-center, Clinical Investigation to Evaluate the Effectiveness of Two NRL Condoms With Benzocaine Paste Compared With a Standard NRL Control in Prolonging Time to Ejaculation in Healthy Adult Men [NCT05255770]0 participants (Actual)Interventional2022-04-30Withdrawn(stopped due to Change of the product development strategy)
Effectiveness of Health Coaching to Reduce Cardiometabolic Risk in Early Home Visiting Services [NCT05619705]360 participants (Anticipated)Interventional2023-04-25Recruiting
Effectiveness of Synapse Transcutaneous Electronic Nerve Stimulation (TENS) Device in Reducing Pain Among Children 6-14 Years During Dental Treatments in a Randomized Cross-over Clinical Trial [NCT03779659]0 participants (Actual)Interventional2021-07-31Withdrawn(stopped due to Prior to IRB submission, Covid-19 related logistical and personnel issues led to the decision to not move forward with this research.)
The Efficacy of Pedagogical Framework (Learn, See, Practice, Prove, Do, Maintain) on Knowledge, Skill, and Self-Efficacy of Nursing Students Regarding Neonatal Resuscitation. [NCT04748341]62 participants (Actual)Interventional2021-02-10Completed
Platelet Rich-plasma in Management of Chronic Multiple Oral Ulcers [NCT03878771]Phase 1804 participants (Actual)Interventional2019-03-13Completed
Phase 2, Multicenter, Placebo-controlled, Double-masked, Randomized Study to Demonstrate Reliability and Validity of FAECC Scale (Modified FLACC) to Evaluate Relief of Pain in Subjects With Acute Otitis Media Aged >/=2 Months to <5 Years [NCT01588535]Phase 238 participants (Actual)Interventional2012-05-31Completed
Pragmatic Research in Healthcare Settings to Improve Diabetes and Obesity Prevention and Care for Our Program MAINTAIN PRIME (Promoting Real (World) IMplEmentation Through Care Teams). [NCT04420936]269 participants (Actual)Interventional2021-09-08Active, not recruiting
Evaluation of Posterior Segment Intrusion Using Miniplates in Skeletal ClassII Hyperdivergent Adolescence: A Randomized Control Trial [NCT02674191]24 participants (Actual)Interventional2016-05-31Active, not recruiting
Brain Health Together: A Live-Streaming Group-Based Digital Program [NCT05818423]216 participants (Anticipated)Interventional2023-04-10Recruiting
Efficacy, Immunogenicity and Safety of Recombinant Vaccine Against Herpes Zoster (RZV or SHINGRIX®) in Patients With Autoimmune Rheumatic Diseases [NCT05879419]Phase 42,005 participants (Anticipated)Interventional2023-05-23Recruiting
The Impact of Adequate Water Intake on Exercise Performance and Mood in Women and Men [NCT05033665]217 participants (Actual)Interventional2021-05-26Completed
Can a Behavioural Modifying Intervention Increase the Self-care and the Effect of the Diabetes Treatment in Chronically Ill Patients With Diabetes [NCT00555854]349 participants (Actual)Interventional2005-12-31Completed
Effect of Antibacterial Mouthwash on Muscle Function in Healthy Young Men and Women [NCT04095442]32 participants (Actual)Interventional2019-11-01Completed
Phase II, Multicenter, Double-Blind, Randomized, Vehicle-Controlled Study to Assess the Safety and Efficacy of Benzocaine for Pain Relief in Children Ages 2 Months to 12 Years Presenting With Acute Otitis Media [NCT02092454]Phase 265 participants (Actual)Interventional2013-09-30Completed
A Phase 3, Multicenter, Placebo-controlled, Double-blind, Randomized Study to Compare the Efficacy and Safety of AR01 Otic Solution to a Placebo Solution for Relief of Pain in Acute Otitis Media Subjects Aged 2 Months to 19 Years [NCT02074007]Phase 3178 participants (Actual)Interventional2013-12-31Terminated(stopped due to primary outcome measure not met)
A Two-Part Phase I Study to Establish and Compare the Safety and Local Tolerability of Two Nasal Formulations of XF-73 for Decolonization of Staphylococcus Aureus: A Previously Investigated 0.5 mg/g Viscosified Gel Formulation Versus a Modified Formulatio [NCT01592214]Phase 148 participants (Actual)Interventional2012-08-31Completed
Efficacy and Tolerability of Ambroxol Lozenge 20 mg in Relieving Pain of Sore Throat in Patients With Acute Viral Pharyngitis-A Randomised, Double-blind,Placebo- and Active-controlled Parallel Group Study [NCT00148499]Phase 3751 participants Interventional2005-10-31Completed
Benzocaine Gel Toothache Dose-Response Study [NCT00474175]Phase 4577 participants (Actual)Interventional2007-05-31Completed
Role of the Foregut in Nutrient Metabolism in Lean and Obese Humans [NCT02537314]Phase 127 participants (Actual)Interventional2015-09-30Completed
Unicentric Comparing Effectiveness of Polymyxin B Sulphate + Prednisolone + Benzocaine + Clioquinol to Betamethasone + Gentamicin + Tolnaftate + Clioquinol in Acute and Sub-acute Dermatitis Eczematous [NCT01429701]Phase 376 participants (Actual)Interventional2012-05-31Completed
Effectiveness of Laser Photobiomodulation Therapy in Reducing Child Pain During Local Anesthesia Injection (a Randomized Controlled Clinical Trial) [NCT05861154]64 participants (Anticipated)Interventional2022-12-01Recruiting
Topical Intrapocket Anesthesia With Prilocaine and Lidocaine as Alternative to Injectable Anesthesia During Scaling and Root Planing - A Randomized Clinical Trial [NCT01860235]32 participants (Actual)Interventional2010-06-30Completed
Effectiveness of Benzocaine Gelpatch in Reducing Injection Pain in Pediatric Dental Patients:A Randomized Clinical Trial [NCT04317508]Phase 1/Phase 250 participants (Actual)Interventional2019-11-01Completed
A Phase 3, Multicenter, Placebo-controlled, Double-blind, Randomized Study to Compare the Efficacy and Safety of AR01 Otic Solution to a Placebo Solution for Relief of Pain in Acute Otitis Media Subjects Aged 2 Months to 19 Years [NCT02044341]Phase 3304 participants (Actual)Interventional2013-12-31Completed
A Double-blind, Partial Cross-over, Incomplete Factorial Study to Assess the Local Anesthetic Efficacy and Safety of CTY-5339 Anesthetic Spray (CTY-5339-A) When Applied to the Cheek Mucosal Tissue in Normal Volunteers [NCT02908620]Phase 240 participants (Actual)Interventional2016-12-07Completed
Evaluation of Diode Laser and Topical Steroid Therapy in the Treatment of Erosive Oral Lichen Planus (A Randomized Controlled Clinical Trial) [NCT05951361]44 participants (Actual)Interventional2022-02-01Completed
KULeuven Intensive Insulin Therapy Study in Medical Intensive Care Patients [NCT00115479]Phase 21,200 participants Interventional2002-03-31Completed
Comparative Evaluation of Different Pain Alleviating Methods During Intra-oral Local Anesthetic Injections in Children : A Randomized Controlled Trial [NCT05564442]224 participants (Anticipated)Interventional2022-06-05Recruiting
An Open Label, Randomised, 3-way Cross-over, Single-centre, Clinical Investigation to Evaluate the Effectiveness of Benzocaine in Two NRL Condoms Compared With a Standard NRL Control Without Benzocaine in Prolonging Time to Ejaculation in Healthy Adult Me [NCT05840172]300 participants (Anticipated)Interventional2023-10-31Not yet recruiting
Comparative Efficacy of 20% Benzocaine Versus TAC Alternate Gel for Control of Pain of Dental Needle Insertion in the Palate [NCT00846690]Phase 420 participants (Anticipated)Interventional2009-01-31Recruiting
Duodenal Lipid Sensing and Nutrient Absorption [NCT01694004]Phase 120 participants (Anticipated)Interventional2012-11-30Enrolling by invitation
A Multi-center, Double-blind, Randomized, Parallel-group, Placebo-controlled Study to Determine the Efficacy and Safety of a Benzocaine Lozenge for Treatment of Sore Throat Caused by URTI in Adults. [NCT03432923]Phase 3260 participants (Actual)Interventional2018-02-02Completed
A Randomized Controlled Trial of Benzocaine Versus Placebo Spray for Pain Relief at Hysterosalpingogram [NCT01925469]Phase 430 participants (Actual)Interventional2011-12-31Completed
Decision Support for Intraoperative Low Blood Pressure [NCT02726620]22,435 participants (Actual)Interventional2017-01-05Completed
Effectiveness of Pre Injection Use of Cryoanesthesia as Compared to Topical Anesthetic Gel in Reducing Pain Perception During Palatal Injections [NCT06165432]Phase 460 participants (Actual)Interventional2021-03-19Completed
A Comparison of Oxygen Saturation Between Lateral Decubitus Lung Surgery and Port Access Procedures in Dorsal Decubitus [NCT01744886]29 participants (Actual)Interventional2012-12-31Terminated(stopped due to Inacceptable oxygen saturation values in one study group)
Training in the Fasted State, Glucose Metabolism and Energy Balance [NCT02744183]30 participants (Actual)Interventional2016-10-31Completed
CO-OP Trial: Community-based Outreach on Obesity in Pregnancy: Using Community-based Participatory Research to Modify Dietary Interventions to Prevent Excessive Weight Gain During Pregnancy in Obese and Under-resourced Women [NCT01841424]46 participants (Actual)Interventional2013-06-30Completed
A Double-Blind, Randomized, Split-Face Comparison Trial on Topical Anesthetic Agents Prior to Fractional Skin Resurfacing [NCT01842373]0 participants (Actual)Interventional2013-07-31Withdrawn(stopped due to Funding not secured)
A Four-arm, Randomized, Double-blind, Active and Placebo Controlled Study to Determine the Safety and Efficacy of a Combination Antipyrine and Benzocaine Otic Solution Compared With Antipyrine Otic Solution Alone, Benzocaine Otic Solution Alone and to Pla [NCT02037893]Phase 2112 participants (Actual)Interventional2013-11-30Completed
Comparison of Efficacy of Two Topical Anesthetics: Benzocaine Versus Pliaglis for Control of Pain Associated With Dental Needle Insertion in the Palate, A Double Blind Study [NCT01951820]Phase 464 participants (Actual)Interventional2013-08-31Completed
Assessing the Efficacy of Antipyrine Benzocaine Otic Solution in the Ear Canal to Decrease Usage of Rescue Inhalers in Moderate to Severe Asthmatic Adults. [NCT02153541]Phase 250 participants (Anticipated)Interventional2023-04-01Not yet recruiting
Open-Label, Randomized, Split-Face Study to Evaluate the Efficacy, Safety and Subject Satisfaction of Pain Management During and After Restylane® Dermal Filler Injections for the Correction of Nasolabial Folds [NCT00716443]Phase 451 participants (Actual)Interventional2008-07-31Terminated(stopped due to Sponsor decision)
Upshots of 5% Emla Cream Versus 20% Benzocaine on Pre-Injection Analgesia. [NCT05060913]Early Phase 170 participants (Actual)Interventional2021-11-17Completed
The Modification of Diet in Renal Disease Study [NCT04364113]Phase 3840 participants (Actual)Interventional1989-01-01Completed
A Double-blind, Cross-over, Incomplete Factorial Study to Assess the Local Anesthetic Efficacy and Safety of CTY-5339 Anesthetic Spray (CTY-5339A) When Applied to the Gingival Mucosal Tissue in Normal Volunteers [NCT03233737]Phase 275 participants (Actual)Interventional2017-06-15Completed
Phase III, Multicenter, Randomized, Double-Blind, Placebo- Controlled Parallel-Designed Evaluation to Assess Safety and Efficacy of Topical Benzocaine for Treatment of Pain Associated With Acute Otitis Media in Children Ages 5 to 12 Years [NCT03116737]Phase 3141 participants (Actual)Interventional2017-01-03Completed
An Open Label Comparing the Short Term Efficacy of Lacrisert [NCT03079271]Phase 450 participants (Anticipated)Interventional2016-11-30Recruiting
Efficacy of Injected Local Anesthetic vs Topical Anesthetic in Cosmetic Injectable Fillers [NCT02379221]49 participants (Actual)Interventional2014-09-30Completed
SUBstituting With Preferred Options: Health Effects of Substituting Sugar-sweetened Beverages With Non-caloric Beverages in Adults With Overweight and Obesity [NCT04567108]460 participants (Anticipated)Interventional2021-04-22Recruiting
Efficacy of Ethyl Chloride Topical Anesthesia Application on the Pain Perception During Intra-oral Injections in Children in Comparison to Benzocaine Gel- a Single-blinded Randomized Controlled Trial. [NCT06011005]42 participants (Anticipated)Interventional2023-09-01Recruiting
Time of Cry After Lingual Frenotomy in Infants With Lingual Frenulum and Breastfeeding Difficulties, With or Without Use of Topical Benzocaine Analgesia [NCT01274247]Phase 1/Phase 221 participants (Actual)Interventional2011-02-28Terminated(stopped due to The study ethics committee recommended concluding the study for longer crying time with benzocaine and very short crying time in all participants.)
MAnagement of Systolic Blood Pressure During Thrombectomy by Endovascular Route for Acute Ischaemic STROKE: the MASTERSTROKE Trial [NCT05645861]550 participants (Anticipated)Interventional2019-11-28Recruiting
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00474175 (10) [back to overview]Duration of Effect
NCT00474175 (10) [back to overview]Sum of Pain Relief Combined With Pain Intensity Differences (SPRID) Scores
NCT00474175 (10) [back to overview]Pain Relief Combined With Pain Intensity Difference (PRID) Scores
NCT00474175 (10) [back to overview]Dosing Compliance Calculated by Evaluating Amount of Study Medication Applied
NCT00474175 (10) [back to overview]Dosing Compliance Calculated by Evaluating Percentage of Participants Who Applied no More Than 400 mg of the Study Medication
NCT00474175 (10) [back to overview]Time to Meaningful Relief
NCT00474175 (10) [back to overview]Global Satisfaction Assessment
NCT00474175 (10) [back to overview]Percentage of Participants With a Response
NCT00474175 (10) [back to overview]Time to Dropping Out Due to Lack of Efficacy or Rescue Medication
NCT00474175 (10) [back to overview]Time to First Confirmed Perceptible Relief
NCT00716443 (15) [back to overview]Number of Participants With Tolerability Assessments Resulting in Adverse Events From Baseline to Two Days After Injection of Restylane® Into the Nasolabial Folds
NCT00716443 (15) [back to overview]"Number of Participants Who Answered the Question Still Speaking to the Topical Anesthetic You Had on the Right/Left Side of Your Face, Would You Recommend it to Your Friend or Family Member? 3 Hours After Injection of Restylane® Into Nasolabial Folds"
NCT00716443 (15) [back to overview]"Number of Participants Who Answered the Question What Level of Pain Did You Experience When You Were Injected? Three Hours After Injection of Restylane® Into the Nasolabial Folds"
NCT00716443 (15) [back to overview]"Number of Participants With Yes/no Answers to Question to Investigator Did the Topical Anesthetics Provide Adequate Anesthesia for the Injections of Restylane® Into the Nasolabial Folds Procedure? Day of Injection of Restylane® Into Nasolabial Folds"
NCT00716443 (15) [back to overview]Number of Participants in Each Category of the Blinded Evaluator's Evaluation of Subject's Pain Scale Immediately After Injection of Restylane® Into the Nasolabial Folds
NCT00716443 (15) [back to overview]Number of Participants in Each Category of the Blinded Evaluator's Evaluation of Subject's Pain Scale One Hour After Injection of Restylane® Into the Nasolabial Folds
NCT00716443 (15) [back to overview]Number of Participants in Each Category of the Blinded Evaluator's Evaluation of Subject's Pain Scale Three Hours After Injection of Restylane® Into the Nasolabial Folds
NCT00716443 (15) [back to overview]Number of Participants in Each Category of the Blinded Evaluator's Evaluation of Subject's Pain Scale Upon First Needle Stick of Injection of Restylane® Into the Nasolabial Folds
NCT00716443 (15) [back to overview]"Number of Participants Who Answered the Question If You Experienced Pain, Was it What You Expected From the Injection Procedure? Three Hours After Injection of Restylane® Into the Nasolabial Folds"
NCT00716443 (15) [back to overview]Number of Participants in Each Category of the Investigator Evaluation of the Subject's Post Procedure Pain Assessment Scale Immediately After Injection of Restylane® Into the Nasolabial Folds
NCT00716443 (15) [back to overview]Number of Participants in Each Category of the Investigator Evaluation of the Subject's Post Procedure Pain Assessment Scale Upon First Needle Stick of Injection of Restylane® Into the Nasolabial Folds
NCT00716443 (15) [back to overview]Number of Participants in Each Category of the Investigator's Evaluation of Subject's Pain Scale One Hour After Injection of Restylane® Into the Nasolabial Folds
NCT00716443 (15) [back to overview]Number of Participants in Each Category of the Investigator's Evaluation of Subject's Pain Scale Three Hours After Injection of Restylane® Into the Nasolabial Folds
NCT00716443 (15) [back to overview]Subject's Pain Evaluation by Visual Analog Scale (VAS)Upon First Needlestick, Immediately After Injection, One Hour After Injection and Three Hours After Injection of Restylane® Into the Nasolabial Folds
NCT00716443 (15) [back to overview]"Number of Participants Who Answered the Question If it Was Different Than What You Expected, Was it? Three Hours After Injection of Restylane® Into the Nasolabial Folds"
NCT01925469 (3) [back to overview]Patient Satisfaction
NCT01925469 (3) [back to overview]Change in Pain Score From Pre-procedure to 5 Minutes Post Procedure.
NCT01925469 (3) [back to overview]Change in Pain Score
NCT01951820 (1) [back to overview]Measurement of Pain Associated With Injection, in Millimeters, According to Visual Analog Scale
NCT02037893 (11) [back to overview]Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 60 Hours Post First Dose
NCT02037893 (11) [back to overview]Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R)15 Min Post First Dose
NCT02037893 (11) [back to overview]Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 72 Hours Post First Dose
NCT02037893 (11) [back to overview]Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 6 Hours Post First Dose
NCT02037893 (11) [back to overview]Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 48 Hours Post First Dose
NCT02037893 (11) [back to overview]Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 30 Min Post First Dose
NCT02037893 (11) [back to overview]Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 3 Hour Post First Dose
NCT02037893 (11) [back to overview]Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 24 Hours Post First Dose
NCT02037893 (11) [back to overview]Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 12 Hours Post First Dose
NCT02037893 (11) [back to overview]Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 36 Hours Post First Dose
NCT02037893 (11) [back to overview]Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R)
NCT02379221 (6) [back to overview]Participants Anesthetic Preference
NCT02379221 (6) [back to overview]Mean Pain Level Associated With Facial Filler Injection at the Upper Lip
NCT02379221 (6) [back to overview]Mean Pain Level Associated With Facial Filler Injection to the Lower Lip
NCT02379221 (6) [back to overview]Mean Pain Level Associated With Facial Filler Injection to the Nasolabial Fold
NCT02379221 (6) [back to overview]Mean Pain Level Associated With the Local Anesthetic Injection
NCT02379221 (6) [back to overview]Mean Pain Level Associated With the Local Topical Anesthetic
NCT02726620 (43) [back to overview]Incidence of a MAP < 55 mmHg for > 20 Minutes
NCT02726620 (43) [back to overview]Incidence of a MAP < 60 mmHg
NCT02726620 (43) [back to overview]Incidence of a MAP < 60 mmHg for > 20 Minutes
NCT02726620 (43) [back to overview]Intraoperative Administration of Intravenous Fluids
NCT02726620 (43) [back to overview]Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 50 mmHg
NCT02726620 (43) [back to overview]Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 55 mmHg
NCT02726620 (43) [back to overview]Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 60 mmHg
NCT02726620 (43) [back to overview]Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 65 mmHg
NCT02726620 (43) [back to overview]Postoperative Rise in Creatinine Levels
NCT02726620 (43) [back to overview]Time to Discharge Readiness at the Postanesthesia Care Unit (PACU)
NCT02726620 (43) [back to overview]Timing of Cardiovascular Drugs for MAP < 50 mmHg
NCT02726620 (43) [back to overview]Timing of Cardiovascular Drugs for MAP < 55 mmHg
NCT02726620 (43) [back to overview]Timing of Cardiovascular Drugs for MAP < 60 mmHg
NCT02726620 (43) [back to overview]Timing of Cardiovascular Drugs for MAP < 65 mmHg
NCT02726620 (43) [back to overview]Usage Frequency of Cardiovascular Drugs: Ephedrine
NCT02726620 (43) [back to overview]Usage Frequency of Cardiovascular Drugs: Ephinephrine
NCT02726620 (43) [back to overview]Incidence of a MAP < 60 mmHg for > 10 Minutes
NCT02726620 (43) [back to overview]Usage Frequency of Cardiovascular Drugs: Norepinephrine
NCT02726620 (43) [back to overview]Usage Frequency of Cardiovascular Drugs: Phenylephrine
NCT02726620 (43) [back to overview]Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 50 mmHg
NCT02726620 (43) [back to overview]Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 55 mmHg
NCT02726620 (43) [back to overview]Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 60 mmHg
NCT02726620 (43) [back to overview]Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 65 mmHg
NCT02726620 (43) [back to overview]Usage Frequency of Cardiovascular Drugs: Glycopyrrolate
NCT02726620 (43) [back to overview]Average Use of Cardiovascular Drugs: Norepinephrine
NCT02726620 (43) [back to overview]30-day Mortality
NCT02726620 (43) [back to overview]Average Use of Cardiovascular Drugs: Ephedrine
NCT02726620 (43) [back to overview]Average Use of Cardiovascular Drugs: Epinephrine
NCT02726620 (43) [back to overview]Average Use of Cardiovascular Drugs: Glycopyrrolate
NCT02726620 (43) [back to overview]Average Use of Cardiovascular Drugs: Phenylephrine
NCT02726620 (43) [back to overview]Depth and Duration of Intraoperative Hypotension - Threshold MAP 50 mmHg
NCT02726620 (43) [back to overview]Depth and Duration of Intraoperative Hypotension - Threshold MAP 55 mmHg
NCT02726620 (43) [back to overview]Depth and Duration of Intraoperative Hypotension - Threshold MAP 60 mmHg
NCT02726620 (43) [back to overview]Depth and Duration of Intraoperative Hypotension - Threshold MAP 65 mmHg
NCT02726620 (43) [back to overview]Depth and Duration of Intraoperative Hypotension - Threshold MAP 70 mmHg
NCT02726620 (43) [back to overview]Depth and Duration of Intraoperative Hypotension - Threshold MAP 75 mmHg
NCT02726620 (43) [back to overview]Estimated Intraoperative Blood Loss
NCT02726620 (43) [back to overview]In-hospital Mortality
NCT02726620 (43) [back to overview]Incidence of a MAP < 50 mmHg
NCT02726620 (43) [back to overview]Incidence of a MAP < 50 mmHg for > 10 Minutes
NCT02726620 (43) [back to overview]Incidence of a MAP < 50 mmHg for > 20 Minutes
NCT02726620 (43) [back to overview]Incidence of a MAP < 55 mmHg
NCT02726620 (43) [back to overview]Incidence of a MAP < 55 mmHg for > 10 Minutes
NCT02908620 (10) [back to overview]Percentage of Responders for PPT at Each Time Point
NCT02908620 (10) [back to overview]Duration of Anesthesia as Measured by Pin Prick Test (PPT) for One Spray CTY-5339-A Compared to One Spray CTY-5339-CB
NCT02908620 (10) [back to overview]Duration of Anesthesia as Measured by Heat Sensation Threshold (QST Heat) for One Spray CTY-5339-A Compared to One Spray CTY-5339-CB
NCT02908620 (10) [back to overview]Onset of Anesthesia for QST Heat
NCT02908620 (10) [back to overview]Duration of Anesthesia as Measured by Pin Prick Test (PPT) for Two Sprays CTY-5339-A Compared to One Spray CTY-5339-CB in Combination With One Spray CTY-5339-P (Placebo)
NCT02908620 (10) [back to overview]Percentage of Responders for QST Heat at Each Time Point
NCT02908620 (10) [back to overview]Onset of Anesthesia for PPT
NCT02908620 (10) [back to overview]Duration of Anesthesia as Measured by QST Heat for Two Sprays CTY-5339-A Compared to One Spray CTY-5339-CB in Combination With One Spray CTY-5339-P (Placebo)
NCT02908620 (10) [back to overview]Duration of Anesthesia as Measured by QST Heat for One Spray CTY-5339-A Compared to Two Sprays CTY-5339-A
NCT02908620 (10) [back to overview]Duration of Anesthesia as Measured by PPT for One Spray CTY-5339-A Compared to Two Sprays CTY-5339-A
NCT03233737 (22) [back to overview]Stage I: Onset of Anesthesia for Heat Sensation Threshold (QST Heat)
NCT03233737 (22) [back to overview]Stage I: Onset of Anesthesia for Pin Prick Test (PPT)
NCT03233737 (22) [back to overview]Stage I: Percentage of Subjects Reaching Maximum Heat for Heat Sensation Threshold (QST Heat)
NCT03233737 (22) [back to overview]Stage I: Percentage of Subjects Reaching Minimal Pain on Pin Prick Test (PPT) (≤2 on Numerical Rating Scale Pain Scale)
NCT03233737 (22) [back to overview]Stage II: Duration of Anesthesia as Measured by Heat Sensation Threshold (QST Heat) for One Spray CTY-5339-A Compared to One Spray CTY-5339-CB
NCT03233737 (22) [back to overview]Stage II: Duration of Anesthesia as Measured by Pin Prick Test (PPT) for One Spray CTY-5339-A Compared to One Spray CTY-5339-CB
NCT03233737 (22) [back to overview]Stage II: Duration of Minimal Pain for Pin Prick Test (PPT) (≤2 on Numerical Rating Scale Pain Scale)
NCT03233737 (22) [back to overview]Stage II: Percentage of Subjects Reaching Maximum Heat for Heat Sensation Threshold (QST Heat)
NCT03233737 (22) [back to overview]Stage II: Onset of Anesthesia for Pin Prick Test (PPT)
NCT03233737 (22) [back to overview]Stage II: Percentage of Subjects Reaching Minimal Pain on Pin Prick Test (PPT) (≤2 on Numerical Rating Scale Pain Scale)
NCT03233737 (22) [back to overview]Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point
NCT03233737 (22) [back to overview]Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point
NCT03233737 (22) [back to overview]Stage I: Sum of Pain Intensity Differences (SPID) for Pin Prick Test (PPT) (Post-hoc)
NCT03233737 (22) [back to overview]Stage I: Sum of Temperature Differences (STID) for Heat Sensation Threshold (QST Heat) (Post-hoc)
NCT03233737 (22) [back to overview]Stage II: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point
NCT03233737 (22) [back to overview]Stage II: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point
NCT03233737 (22) [back to overview]Stage II: Sum of Pain Intensity Differences (SPID) for Pin Prick Test (PPT) (Post-hoc)
NCT03233737 (22) [back to overview]Stage II: Sum of Temperature Differences (STID) for Heat Sensation Threshold (QST Heat) (Post-hoc)
NCT03233737 (22) [back to overview]Stage II: Onset of Anesthesia for Heat Sensation Threshold (QST Heat)
NCT03233737 (22) [back to overview]Stage I: Duration of Anesthesia as Measured by Heat Sensation Threshold (QST Heat) for One Spray CTY-5339-A Compared to One Spray CTY-5339-CB Compared to One Spray CTY-5339-P (Placebo: Vehicle Control)
NCT03233737 (22) [back to overview]Stage I: Duration of Anesthesia as Measured by Pin Prick Test (PPT) for One Spray CTY-5339-A Compared to One Spray CTY-5339-CB Compared to One Spray CTY-5339-P (Placebo: Vehicle Control)
NCT03233737 (22) [back to overview]Stage I: Duration of Minimal Pain for Pin Prick Test (PPT) (≤2 on Numerical Rating Scale Pain Scale)
NCT04748341 (3) [back to overview]Neonatal Resuscitation Checklist
NCT04748341 (3) [back to overview]Self-efficacy for Neonatal Resuscitation (SENR)
NCT04748341 (3) [back to overview]Knowledge Questionnaire

Duration of Effect

Duration of effect was defined as the time difference between onset of effect and its offset. Onset of effect was the first time point at which two consecutive pain scores less severe than at baseline by at least 1 unit (on the DPS) were attained. Offset of effect was the first of the following events to occur after onset: time to drop out if the drop out was due to lack of efficacy, time of rescue medication, or the first time point following onset of effect at which two consecutive pain scores that are at least as severe as at baseline were attained. (NCT00474175)
Timeframe: 0 to 120 minutes

InterventionMinutes (Median)
PlaceboNA
Benzocaine 10%NA
Benzocaine 20%NA

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Sum of Pain Relief Combined With Pain Intensity Differences (SPRID) Scores

SPRID is time-weighted sum of pain relief scores combined with pain intensity difference (PRID) scores over 60 and 120 minutes. SPRID score range was 0 (worst) to 7 (best) for SPRID 60 and 0 (worst) to 14 (best) for SPRID 120. PRID is sum of Pain intensity differences (PID) and Dental pain relief scale (DPRS) scores at each post-dosing time point. PID was calculated as baseline DPS minus DPS score at given time point (DPS range: 0 [none] to 3 [severe]; baseline DPS range from 2-3). PID score ranges from -1 (worst) to 3 (best). DPRS is 5-point scale ranging from 0 (No-relief) to 4 (Complete). (NCT00474175)
Timeframe: 60 minutes and 120 minutes

,,
InterventionUnits on a scale (Mean)
SPRID 60SPRID 120
Benzocaine 10%3.46.4
Benzocaine 20%3.66.7
Placebo3.15.9

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Pain Relief Combined With Pain Intensity Difference (PRID) Scores

PRID is sum of PID and DPRS scores at each post-dosing time point. The overall possible score range, for PRID is -1 (worst) to 7 (best). PID was calculated as baseline DPS minus DPS score at given time point (DPS range from 0 [none] to 3 [severe]; baseline DPS range from 2-3). PID score ranges from -1 (worst) to 3 (best). DPRS is 5-point scale ranging from 0 (No-relief) to 4 (Complete). (NCT00474175)
Timeframe: 5 to 120 minutes

,,
InterventionUnits on a scale (Mean)
5 minutes10 minutes15 minutes20 minutes25 minutes30 minutes40 minutes50 minutes60 minutes70 minutes80 minutes90 minutes100 minutes110 minutes120 minutes
Benzocaine 10%3.253.563.643.643.603.393.443.413.183.163.093.053.002.902.82
Benzocaine 20%3.663.883.963.743.733.663.523.423.383.333.243.092.932.962.84
Placebo2.723.083.183.213.123.113.063.203.172.982.912.782.782.702.73

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Dosing Compliance Calculated by Evaluating Amount of Study Medication Applied

Amount of study medication applied was calculated by weighing medication tube prior and post-dosing. (NCT00474175)
Timeframe: Baseline and 5 minutes

InterventionMilligram (mg) (Mean)
Placebo258.6
Benzocaine 10%226.8
Benzocaine 20%233.1

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Dosing Compliance Calculated by Evaluating Percentage of Participants Who Applied no More Than 400 mg of the Study Medication

(NCT00474175)
Timeframe: Baseline and 5 minutes

InterventionPercentage of participants (Number)
Placebo83.5
Benzocaine 10%89.3
Benzocaine 20%89.5

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Time to Meaningful Relief

Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled 'meaningful relief' at the moment they first began to experience meaningful relief. Stopwatch was active up to 120 minutes after dosing or until stopped by the participant, or rescue medication was administered. (NCT00474175)
Timeframe: 0 to 120 minutes

InterventionMinutes (Median)
Placebo8.5
Benzocaine 10%4.4
Benzocaine 20%3.2

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Global Satisfaction Assessment

Participants were asked to provide an overall assessment of their satisfaction with the study medication on a categorical scale. Response in this scale was assigned values as 0 (Poor), 1 (Fair), 2 (Good), 3 (Very Good) and 4 (Excellent). (NCT00474175)
Timeframe: 120 minutes

InterventionUnits on a scale (Mean)
Placebo2.1
Benzocaine 10%2.5
Benzocaine 20%2.5

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Percentage of Participants With a Response

Responder was defined as participant experiencing improvement in pain intensity, as exhibited by a pain score reduction on the Dental Pain Scale (DPS) from baseline of at least 1 unit for two consecutive assessments anytime between the 5 and 20-minute time points. Response in DPS scale was assigned values as 0 (None), 1 (Mild), 2 (Moderate) and 3 (Severe). (NCT00474175)
Timeframe: Baseline, 5, 10, 15 and 20 minutes

InterventionPercentage of participants (Number)
Placebo70.4
Benzocaine 10%80.7
Benzocaine 20%87.3

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Time to Dropping Out Due to Lack of Efficacy or Rescue Medication

Median time of dropping out of the participants from the study due to lack of efficacy or rescue medication (ibuprofen 200-400 mg or acetaminophen 1000 mg), whichever comes first. (NCT00474175)
Timeframe: 0 to 120 minutes

InterventionMinutes (Median)
PlaceboNA
Benzocaine 10%NA
Benzocaine 20%NA

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Time to First Confirmed Perceptible Relief

Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment they first began to experience any relief. Stopwatch was active up to 120 minutes after dosing or until stopped by the participant, or rescue medication was administered. (NCT00474175)
Timeframe: 0 to 120 minutes

InterventionMinutes (Median)
Placebo2.0
Benzocaine 10%1.4
Benzocaine 20%1.1

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Number of Participants With Tolerability Assessments Resulting in Adverse Events From Baseline to Two Days After Injection of Restylane® Into the Nasolabial Folds

Number of participants w/ tolerability assessments (erythema, edema, blanching) resulting in adverse events from Baseline to two days after injection of Restylane® into the nasolabial folds (NCT00716443)
Timeframe: Baseline to two days after injection of Restylane® into the nasolabial folds

Interventionparticipants (Number)
Pliaglis® Cream0
Compounded Topical Anesthetic Ointment0

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"Number of Participants Who Answered the Question Still Speaking to the Topical Anesthetic You Had on the Right/Left Side of Your Face, Would You Recommend it to Your Friend or Family Member? 3 Hours After Injection of Restylane® Into Nasolabial Folds"

"Number of participants who answered No, Yes or No response to the question Still speaking to the topical anesthetic you had on the right/left side of your face, would you recommend it to your friend or family member? three hours after injection of Restylane® into the nasolabial folds" (NCT00716443)
Timeframe: three hours after injection of Restylane® into the nasolabial folds

,
Interventionparticipants (Number)
NoYesNo response
Compounded Topical Anesthetic Ointment12390
Pliaglis® Cream13380

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"Number of Participants Who Answered the Question What Level of Pain Did You Experience When You Were Injected? Three Hours After Injection of Restylane® Into the Nasolabial Folds"

"Number of participants who answered according to a scale of None, Minimal, Mild, Moderate, Severe, or No response to the question What level of pain did you experience when you were injected? three hours after injection of Restylane® into the nasolabial folds" (NCT00716443)
Timeframe: three hours after injection of Restylane® into the nasolabial folds

,
Interventionparticipants (Number)
NoneMinimalMildModerateSevereNo response
Compounded Topical Anesthetic Ointment22415910
Pliaglis® Cream42315810

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"Number of Participants With Yes/no Answers to Question to Investigator Did the Topical Anesthetics Provide Adequate Anesthesia for the Injections of Restylane® Into the Nasolabial Folds Procedure? Day of Injection of Restylane® Into Nasolabial Folds"

"Number of participants with yes or no answers to question asked to investigator on the day of injection of Restylane® into the nasolabial folds Did the topical anesthetics provided adequate anesthesia for the injections of Restylane® into the nasolabial folds procedure?" (NCT00716443)
Timeframe: Day of injection of Restylane® into the nasolabial folds

,
Interventionparticipants (Number)
YesNo
Compounded Topical Anesthetic Ointment447
Pliaglis® Cream447

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Number of Participants in Each Category of the Blinded Evaluator's Evaluation of Subject's Pain Scale Immediately After Injection of Restylane® Into the Nasolabial Folds

Number of participants in each category of the Blinded Evaluator's Evaluation of Subject's Pain scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) immediately after injection of Restylane® into the nasolabial folds (NCT00716443)
Timeframe: immediately after injection of Restylane® into the nasolabial folds

,
Interventionparticipants (Number)
No painSlight painModerate painSevere pain
Compounded Topical Anesthetic Ointment281841
Pliaglis® Cream351150

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Number of Participants in Each Category of the Blinded Evaluator's Evaluation of Subject's Pain Scale One Hour After Injection of Restylane® Into the Nasolabial Folds

Number of participants in each category of the Blinded Evaluator's Evaluation of Subject's Pain scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) one hour after an injection of Restylane® into the nasolabial folds (NCT00716443)
Timeframe: one hour after injection of Restylane® into the nasolabial folds

,
Interventionparticipants (Number)
No painSlight painModerate painSevere pain
Compounded Topical Anesthetic Ointment49200
Pliaglis® Cream49200

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Number of Participants in Each Category of the Blinded Evaluator's Evaluation of Subject's Pain Scale Three Hours After Injection of Restylane® Into the Nasolabial Folds

Number of participants in each category of the Blinded Evaluator's Evaluation of Subject's Pain scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) three hours after injection of Restylane® into the nasolabial folds (NCT00716443)
Timeframe: three hours after injection of Restylane® into the nasolabial folds

,
Interventionparticipants (Number)
No painMild painModerate painSevere pain
Compounded Topical Anesthetic Ointment50100
Pliaglis® Cream50100

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Number of Participants in Each Category of the Blinded Evaluator's Evaluation of Subject's Pain Scale Upon First Needle Stick of Injection of Restylane® Into the Nasolabial Folds

Number of participants in each category of the Blinded Evaluator's Evaluation of Subject's Pain scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) upon first needle stick of an injection of Restylane® into the nasolabial folds (NCT00716443)
Timeframe: upon first needle stick of injection of Restylane® into the nasolabial folds

,
Interventionparticipants (Number)
No painMild painModerate painSevere pain
Compounded Topical Anesthetic Ointment929130
Pliaglis® Cream143160

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"Number of Participants Who Answered the Question If You Experienced Pain, Was it What You Expected From the Injection Procedure? Three Hours After Injection of Restylane® Into the Nasolabial Folds"

"Number of participants who answered No, Yes, Had no expectations or No response to the question If you experienced pain, was it what you expected from the injection procedure? three hours after injection of Restylane® into the nasolabial folds" (NCT00716443)
Timeframe: three hours after injection of Restylane® into the nasolabial folds

,
Interventionparticipants (Number)
NoYesHad no expectationsNo response
Compounded Topical Anesthetic Ointment829131
Pliaglis® Cream1027122

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Number of Participants in Each Category of the Investigator Evaluation of the Subject's Post Procedure Pain Assessment Scale Immediately After Injection of Restylane® Into the Nasolabial Folds

Number of participants in each category of the Investigator Evaluation of the Subject's Post Procedure Pain Assessment scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) immediately after injection of Restylane® into the nasolabial folds immediately after injection of Restylane® into the nasolabial folds (NCT00716443)
Timeframe: immediately after injection of Restylane® into the nasolabial folds

,
Interventionparticipants (Number)
No painSlight painModerate painSevere pain
Compounded Topical Anesthetic Ointment291570
Pliaglis® Cream351060

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Number of Participants in Each Category of the Investigator Evaluation of the Subject's Post Procedure Pain Assessment Scale Upon First Needle Stick of Injection of Restylane® Into the Nasolabial Folds

Number of participants in each category of the Investigator Evaluation of the Subject's Post Procedure Pain Assessment scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) upon first needle stick of an injection of Restylane® into the nasolabial folds (NCT00716443)
Timeframe: Upon first needle stick of injection of Restylane® into the nasolabial folds

,
Interventionparticipants (Number)
No painSlight painModerate painSevere pain
Compounded Topical Anesthetic Ointment1325121
Pliaglis® Cream172860

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Number of Participants in Each Category of the Investigator's Evaluation of Subject's Pain Scale One Hour After Injection of Restylane® Into the Nasolabial Folds

Number of participants in each category of the Investigator's Evaluation of Subject's Pain scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) one hour after injection of Restylane® into the nasolabial folds (NCT00716443)
Timeframe: one hour after injection of Restylane® into the nasolabial folds

,
Interventionparticipants (Number)
No painSlight painModerate painSevere pain
Compounded Topical Anesthetic Ointment49200
Pliaglis® Cream49200

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Number of Participants in Each Category of the Investigator's Evaluation of Subject's Pain Scale Three Hours After Injection of Restylane® Into the Nasolabial Folds

Number of participants in each category of the Investigator's Evaluation of Subject's Pain scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) three hours after injection of Restylane® into the nasolabial folds (NCT00716443)
Timeframe: three hours after injection of Restylane® into the nasolabial folds

,
Interventionparticipants (Number)
No painMild painModerate painSevere pain
Compounded Topical Anesthetic Ointment49200
Pliaglis® Cream50100

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Subject's Pain Evaluation by Visual Analog Scale (VAS)Upon First Needlestick, Immediately After Injection, One Hour After Injection and Three Hours After Injection of Restylane® Into the Nasolabial Folds

Subject's pain as evaluated using a VAS scale from 0 - 10 cm (centimeters) with 0 cm being no pain and 10 cm being the worst pain imaginable upon first needlestick, immediately after injection, one hour after injection and three hours after injection of Restylane® into the nasolabial folds (NCT00716443)
Timeframe: upon first needlestick, immediately after injection, one hour after injection and three hours after injection of Restylane® into the nasolabial folds

,
Interventioncentimeters (Mean)
upon first needle stickimmediately after injectionone hour after injectionthree hours after injection
Compounded Topical Anesthetic Ointment2.82.80.60.5
Pliaglis® Cream2.32.70.80.5

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"Number of Participants Who Answered the Question If it Was Different Than What You Expected, Was it? Three Hours After Injection of Restylane® Into the Nasolabial Folds"

"Number of participants who answered the question If it was different than what you expected, was it? (More pain, Less pain or No response) three hours after injection of Restylane® into the nasolabial folds" (NCT00716443)
Timeframe: three hours after injection of Restylane® into the nasolabial folds

,
Interventionparticipants (Number)
More painLess painNo response
Compounded Topical Anesthetic Ointment91428
Pliaglis® Cream101427

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Patient Satisfaction

The patient's satisfaction will be assessed using a validated satisfaction scale 30 minutes post procedure. (NCT01925469)
Timeframe: 30 minutes post procedure

,
Interventionparticipants (Number)
Extremely satisfiedVery satisfiedSatisfied
Benzocaine1022
Saline Spray1040

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Change in Pain Score From Pre-procedure to 5 Minutes Post Procedure.

The patients pain scores will also be assessed at 5 minutes post procedure and the change in pain scores from baseline to this time points will be analyzed. The pain scores will be subtracted to obtain the change in pain score (NCT01925469)
Timeframe: 5 minutes

Interventionmm (Median)
Benzocaine-11.1
Saline Spray-37

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Change in Pain Score

The primary outcome is the difference in pain score using a validated visual analog scale before the procedure, which is designated as the pre-procedure (or baseline) pain score to the maximum pain during procedure (designated as time 0) These two pain scores will be subtracted and the change in pain score will be reported. The validated visual analog scale allows patients to report pain on a scale of 0 to 100 mm long. At the beginning and at the end, there are two descriptors representing extremes of pain (i.e. no pain = 0 and extreme pain = 100). The patient rated her pain by making a vertical mark on the 100-mm line. The measurement in millimeters was converted to the same number of points ranging from 0 to 100 points. There are no subgroups. (NCT01925469)
Timeframe: Pre-procedure (Baseline) and procedure (Time 0)

Interventionmm (Median)
Benzocaine50.6
Saline Spray70.4

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Measurement of Pain Associated With Injection, in Millimeters, According to Visual Analog Scale

The investigation is trying to determine if the compounded topical anesthetic (Pliaglis) is more effective than the active control (benzocaine) in numbing the gums before needle penetration. The effectiveness of the topical anesthetics will be determined by the patient indicating their level of discomfort felt upon needle stick by using a Heft-Parker visual analog pain scale (scale of 0 - 170mm with 0mm equating to no pain and 170mm equating to maximum pain). (NCT01951820)
Timeframe: 2.5 minutes

Interventionmm (Mean)
Benzocaine38.5
Pliaglis26.9

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Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 60 Hours Post First Dose

"The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.~The FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.~The FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain." (NCT02037893)
Timeframe: Change from Baseline to 60 hour post first dose

Interventionunits on a scale (Mean)
Antipyrine and Benzocaine Otic Solution-5.4
Antipyrine Otic Solution-5.4
Benzocaine Otic Solution-5.4
Placebo-6.2

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Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R)15 Min Post First Dose

"The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.~The FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.~The FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain." (NCT02037893)
Timeframe: Change from Baseline to 15 min post first dose

Interventionunits on a scale (Mean)
Antipyrine and Benzocaine Otic Solution-3.6
Antipyrine Otic Solution-3.6
Benzocaine Otic Solution-3.4
Placebo-3.8

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Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 72 Hours Post First Dose

"The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.~The FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.~The FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain." (NCT02037893)
Timeframe: Change from Baseline to 72 hour post first dose

Interventionunits on a scale (Mean)
Antipyrine and Benzocaine Otic Solution-5.9
Antipyrine Otic Solution-5.9
Benzocaine Otic Solution-5.4
Placebo-6.1

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Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 6 Hours Post First Dose

"The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.~The FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.~The FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain." (NCT02037893)
Timeframe: Change from Baseline to 6 hour post first dose

Interventionunits on a scale (Mean)
Antipyrine and Benzocaine Otic Solution-3.4
Antipyrine Otic Solution-4.0
Benzocaine Otic Solution-3.9
Placebo-3.8

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Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 48 Hours Post First Dose

"The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.~The FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.~The FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain." (NCT02037893)
Timeframe: Change from Baseline to 48 hour post first dose

Interventionunits on a scale (Mean)
Antipyrine and Benzocaine Otic Solution-5.4
Antipyrine Otic Solution-5.3
Benzocaine Otic Solution-4.7
Placebo-5.9

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Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 30 Min Post First Dose

"The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.~The FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.~The FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain." (NCT02037893)
Timeframe: Change from Baseline to 30 min post first dose

Interventionunits on a scale (Mean)
Antipyrine and Benzocaine Otic Solution-3.9
Antipyrine Otic Solution-4.3
Benzocaine Otic Solution-4.4
Placebo-4.8

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Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 3 Hour Post First Dose

"The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.~The FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.~The FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain." (NCT02037893)
Timeframe: Change from Baseline to 3 hour post first dose

Interventionunits on a scale (Mean)
Antipyrine and Benzocaine Otic Solution-3.4
Antipyrine Otic Solution-3.9
Benzocaine Otic Solution-3.8
Placebo-3.5

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Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 24 Hours Post First Dose

"The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.~The FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.~The FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain." (NCT02037893)
Timeframe: Change from Baseline to 24 hour post first dose

Interventionunits on a scale (Mean)
Antipyrine and Benzocaine Otic Solution-5.5
Antipyrine Otic Solution-4.4
Benzocaine Otic Solution-4.2
Placebo-4.6

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Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 12 Hours Post First Dose

"The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.~The FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.~The FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain." (NCT02037893)
Timeframe: Change from Baseline to 12 hour post first dose

Interventionunits on a scale (Mean)
Antipyrine and Benzocaine Otic Solution-3.9
Antipyrine Otic Solution-4.3
Benzocaine Otic Solution-4.1
Placebo-4.0

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Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 36 Hours Post First Dose

"The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.~The FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.~The FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain." (NCT02037893)
Timeframe: Change from Baseline to 36 hour post first dose

Interventionunits on a scale (Mean)
Antipyrine and Benzocaine Otic Solution-5.5
Antipyrine Otic Solution-4.6
Benzocaine Otic Solution-4.4
Placebo-5.5

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Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R)

"The FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.~The FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain." (NCT02037893)
Timeframe: Baseline and 1 hour after a single dose

Interventionunits on a scale (Mean)
Antipyrine and Benzocaine Otic Solution-4.3
Antipyrine Otic Solution-5.0
Benzocaine Otic Solution-4.6
Placebo-4.9

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Participants Anesthetic Preference

Patient will complete a questionnaire to evaluate his/her preference of anesthetic modality. (NCT02379221)
Timeframe: one week post treatment

Interventionparticipant preference selection (Number)
Injectable32
Topical16

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Mean Pain Level Associated With Facial Filler Injection at the Upper Lip

Participant will complete a questionnaire to evaluate his/her pain level perception using a Visual Analog Scale (VAS) during injection of HA filler to the upper lip. The Visual Analog scale uses a 10 cm horizontal line with 'no pain' labeled on the left end of line and 'worst pain' on the right end of line. Participant marks their pain level at any point on the line from no pain to worst pain. No pain= 0 cm, Worst pain=10cm (NCT02379221)
Timeframe: 5-10 minutes post procedure

Interventionunits on a scale (Mean)
Injectable0.89
Topical3.67

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Mean Pain Level Associated With Facial Filler Injection to the Lower Lip

A mean level of pain for all participants completing the Visual Analog Scale (VAS) during injection of HA filler to the lower lip. The Visual Analog scale uses a 10 cm horizontal line with 'no pain' labeled on the left end of line and 'worst pain' on the right end of line. Participant marks their pain level at any point on the line from no pain to worst pain. No pain= 0 cm, Worst pain=10cm. The total score was divided by 48. (NCT02379221)
Timeframe: 5-10 minutes post procedure

Interventionunits on a scale (Mean)
Injectable1.47
Topical4.38

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Mean Pain Level Associated With Facial Filler Injection to the Nasolabial Fold

Participant will complete a questionnaire to evaluate his/her pain level perception using a Visual Analog Scale (VAS) during injection of HA filler to the nasolabial fold. The Visual Analog scale uses a 10 cm horizontal line with 'no pain' labeled on the left end of line and 'worst pain' on the right end of line. Participant marks their pain level at any point on the line from no pain to worst pain. No pain= 0 cm, Worst pain=10cm (NCT02379221)
Timeframe: 5-10 minutes post procedure

Interventionunits on a scale (Mean)
Injectable0.76
Topical2.82

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Mean Pain Level Associated With the Local Anesthetic Injection

Participant will complete a questionnaire to evaluate his/her pain level perception using a Visual Analog Scale (VAS) during injection to the upper and lower lip. The Visual Analog scale uses a 10 cm horizontal line with 'no pain' labeled on the left end of line and 'worst pain' on the right end of line. Participant marks their pain level at any point on the line from no pain to worst pain. No pain= 0 cm, Worst pain=10cm (NCT02379221)
Timeframe: 5-10 minutes post-procedure

Interventionunit on a scale (Mean)
Upper Lip2.14
Lower Lip1.89

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Mean Pain Level Associated With the Local Topical Anesthetic

Participant will complete a questionnaire to evaluate his/her pain level perception using a Visual Analog Scale (VAS) during application of topical anesthesia to the upper and lower lip. The Visual Analog scale uses a 10 cm horizontal line with 'no pain' labeled on the left end of line and 'worst pain' on the right end of line. Participant marks their pain level at any point on the line from no pain to worst pain. No pain= 0 cm, Worst pain=10cm (NCT02379221)
Timeframe: 5-10 min post procedure

Interventionunits on a scale (Mean)
Upper Lip0.05
Lower Lip0.11

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Incidence of a MAP < 55 mmHg for > 20 Minutes

Incidence of a mean arterial pressure (MAP) < 55 mmHg for a cumulative duration of all hypotensive episodes of more than 20 minutes during the anesthetic phase of the procedure. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionParticipants (Count of Participants)
Usual Care Group1223
Hypotension Decision Support284

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Incidence of a MAP < 60 mmHg

Incidence of a mean arterial pressure (MAP) < 60 mmHg during anesthesia for 1 minute or more. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionParticipants (Count of Participants)
Usual Care Group13779
Hypotension Decision Support3798

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Incidence of a MAP < 60 mmHg for > 20 Minutes

Incidence of a mean arterial pressure (MAP) < 60 mmHg for a cumulative duration of all hypotensive episodes of more than 20 minutes during the anesthetic phase of the procedure. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionParticipants (Count of Participants)
Usual Care Group3632
Hypotension Decision Support792

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Intraoperative Administration of Intravenous Fluids

Total amount (mL) of intravenous fluids (as defined under interventions) administered during the surgical procedure. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionmL (Median)
Usual Care Group1500.00
Hypotension Decision Support1400.00

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Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 50 mmHg

Average concentrations of propofol infusion rates during MAP < 50 mmHg episodes (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

Interventionmcg/kg/min (propofol) (Median)
Usual Care Group65.00
Hypotension Decision Support50.00

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Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 55 mmHg

Average concentrations of propofol infusion rates during MAP < 55 mmHg episodes (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

Interventionmcg/kg/min (propofol) (Median)
Usual Care Group63.95
Hypotension Decision Support50.00

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Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 60 mmHg

Average concentrations of propofol infusion rates during MAP < 60 mmHg episodes (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

Interventionmcg/kg/min (propofol) (Median)
Usual Care Group61.07
Hypotension Decision Support50.00

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Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 65 mmHg

Average concentrations of propofol infusion rates during MAP < 65 mmHg episodes (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

Interventionmcg/kg/min (propofol) (Median)
Usual Care Group60.10
Hypotension Decision Support48.59

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Postoperative Rise in Creatinine Levels

Absolute values for serum creatinine before and after surgery will be compared. When multiple postoperative creatinine measurements are made, the maximum difference is reported. (NCT02726620)
Timeframe: Within 7 days after surgery

Interventionmg/dL (Median)
Usual Care Group0.00
Hypotension Decision Support0.00

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Time to Discharge Readiness at the Postanesthesia Care Unit (PACU)

The time from arriving at the postanesthesia care unit (PACU) until the time the patient is considered ready for discharge (in minutes). (NCT02726620)
Timeframe: A specific time frame on the day of surgery: from the start of admission to the PACU to discharge from the PACU, an expected average of 4 hours

Interventionminutes (Median)
Usual Care Group67
Hypotension Decision Support60

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Timing of Cardiovascular Drugs for MAP < 50 mmHg

Cardiovascular drugs as defined under interventions. Time of first administration of cardiovascular drug relative to the time at which the mean arterial pressure (MAP) drops below 50 mmHg. Per patient the average time to first administration of all hypotensive episodes was calculated. That average time is used as the outcome variable. A negative value indicates that administration occurred before the drop in MAP. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

Interventionminutes (Median)
Usual Care Group1
Hypotension Decision Support0

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Timing of Cardiovascular Drugs for MAP < 55 mmHg

Cardiovascular drugs as defined under interventions. Time of first administration of cardiovascular drug relative to the time at which the mean arterial pressure (MAP) drops below 55 mmHg. Per patient the average time to first administration of all hypotensive episodes was calculated. That average time is used as the outcome variable. A negative value indicates that administration occurred before the drop in MAP. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

Interventionminutes (Median)
Usual Care Group1
Hypotension Decision Support0.5

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Timing of Cardiovascular Drugs for MAP < 60 mmHg

Cardiovascular drugs as defined under interventions. Time of first administration of cardiovascular drug relative to the time at which the mean arterial pressure (MAP) drops below 60 mmHg. Per patient the average time to first administration of all hypotensive episodes was calculated. That average time is used as the outcome variable. A negative value indicates that administration occurred before the drop in MAP. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

Interventionminutes (Median)
Usual Care Group0.8
Hypotension Decision Support1.5

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Timing of Cardiovascular Drugs for MAP < 65 mmHg

Cardiovascular drugs as defined under interventions. Time of first administration of cardiovascular drug relative to the time at which the mean arterial pressure (MAP) drops below 60 mmHg. Per patient the average time to first administration of all hypotensive episodes was calculated. That average time is used as the outcome variable. A negative value indicates that administration occurred before the drop in MAP. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

Interventionminutes (Median)
Usual Care Group2
Hypotension Decision Support1.14

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Usage Frequency of Cardiovascular Drugs: Ephedrine

Cardiovascular drugs as defined under interventions. Frequency of patients receiving the drug. Cardiovascular drugs that were given in <1% of cases are not reported. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionParticipants (Count of Participants)
Usual Care Group9310
Hypotension Decision Support2718

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Usage Frequency of Cardiovascular Drugs: Ephinephrine

Cardiovascular drugs as defined under interventions. Frequency of patients receiving the drug. Cardiovascular drugs that were given in <1% of cases are not reported. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionParticipants (Count of Participants)
Usual Care Group1215
Hypotension Decision Support409

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Incidence of a MAP < 60 mmHg for > 10 Minutes

Incidence of a mean arterial pressure (MAP) < 60 mmHg for a cumulative duration of all hypotensive episodes of more than 10 minutes during the anesthetic phase of the procedure. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionParticipants (Count of Participants)
Usual Care Group6989
Hypotension Decision Support1723

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Usage Frequency of Cardiovascular Drugs: Norepinephrine

Cardiovascular drugs as defined under interventions. Frequency of patients receiving the drug. Cardiovascular drugs that were given in <1% of cases are not reported. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionParticipants (Count of Participants)
Usual Care Group762
Hypotension Decision Support233

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Usage Frequency of Cardiovascular Drugs: Phenylephrine

Cardiovascular drugs as defined under interventions. Frequency of patients receiving the drug. Cardiovascular drugs that were given in <1% of cases are not reported. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionParticipants (Count of Participants)
Usual Care Group12211
Hypotension Decision Support3685

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Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 50 mmHg

Average concentrations of inhalational anesthesia during MAP < 50 mmHg episodes (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

,
InterventionEndTidal% (other) (Median)
Sevoflurane (EndTidal %)Isoflurane (EndTidal %)Desflurane (EndTidal %)
Hypotension Decision Support1.230.654.70
Usual Care Group1.320.654.28

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Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 55 mmHg

Average concentrations of inhalational anesthesia during MAP < 55 mmHg episodes (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

,
InterventionEndTidal% (other) (Median)
Sevoflurane (EndTidal %)Isoflurane (EndTidal %)Desflurane (EndTidal %)
Hypotension Decision Support1.250.674.65
Usual Care Group1.340.684.60

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Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 60 mmHg

Average concentrations of inhalational anesthesia during MAP < 60 mmHg episodes (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

,
InterventionEndTidal% (other) (Median)
Sevoflurane (EndTidal %)Isoflurane (EndTidal %)Desflurane (EndTidal %)
Hypotension Decision Support1.250.672.33
Usual Care Group1.350.684.36

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Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 65 mmHg

Average concentrations of inhalational anesthesia during MAP < 65 mmHg episodes (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

,
InterventionEndTidal% (other) (Median)
Sevoflurane (EndTidal %)Isoflurane (EndTidal %)Desflurane (EndTidal %)
Hypotension Decision Support1.270.682.31
Usual Care Group1.350.684.10

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Usage Frequency of Cardiovascular Drugs: Glycopyrrolate

Cardiovascular drugs as defined under interventions. Frequency of patients receiving the drug. Cardiovascular drugs that were given in <1% of cases are not reported. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionParticipants (Count of Participants)
Usual Care Group11093
Hypotension Decision Support1257

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Average Use of Cardiovascular Drugs: Norepinephrine

Cardiovascular drugs as defined under interventions. Average use for each drug will be calculated. Cardiovascular drugs that were given in <1% of cases are not reported, as the average dosage would be meaningless. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

Interventionmg (Median)
Usual Care Group0.62
Hypotension Decision Support0.70

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30-day Mortality

Vanderbilt University Medical Center: combination of in-hospital mortality and 'alive-index' (which checks for visits to the hospital in the electronic healthcare record as indication of being alive at 30 days) (NCT02726620)
Timeframe: 30 days after surgery

InterventionParticipants (Count of Participants)
Usual Care Group511
Hypotension Decision Support143

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Average Use of Cardiovascular Drugs: Ephedrine

Cardiovascular drugs as defined under interventions. Average use for each drug will be calculated. Cardiovascular drugs that were given in <1% of cases are not reported, as the average dosages would be meaningless. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

Interventionmg (Median)
Usual Care Group20
Hypotension Decision Support15

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Average Use of Cardiovascular Drugs: Epinephrine

Cardiovascular drugs as defined under interventions. Average use for each drug will be calculated. Cardiovascular drugs that were given in <1% of cases are not reported, as the average dosage would be meaningless. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

Interventionmg (Median)
Usual Care Group1.00
Hypotension Decision Support0.70

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Average Use of Cardiovascular Drugs: Glycopyrrolate

Cardiovascular drugs as defined under interventions. Average use for each drug will be calculated. Cardiovascular drugs that were given in <1% of cases are not reported, as the average dosage would be meaningless. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

Interventionmg (Median)
Usual Care Group0.40
Hypotension Decision Support0.40

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Average Use of Cardiovascular Drugs: Phenylephrine

Cardiovascular drugs as defined under interventions. Average use for each drug will be calculated. Cardiovascular drugs that were given in <1% of cases are not reported, as the average dosage would be meaningless. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

Interventionmg (Median)
Usual Care Group0.90
Hypotension Decision Support1.30

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Depth and Duration of Intraoperative Hypotension - Threshold MAP 50 mmHg

Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionmmHg*minute (Median)
Usual Care Group19
Hypotension Decision Support19

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Depth and Duration of Intraoperative Hypotension - Threshold MAP 55 mmHg

Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionmmHg*minute (Median)
Usual Care Group23
Hypotension Decision Support23

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Depth and Duration of Intraoperative Hypotension - Threshold MAP 60 mmHg

Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionmmHg*minute (Median)
Usual Care Group57
Hypotension Decision Support52

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Depth and Duration of Intraoperative Hypotension - Threshold MAP 65 mmHg

Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionmmHg*minute (Median)
Usual Care Group96
Hypotension Decision Support86

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Depth and Duration of Intraoperative Hypotension - Threshold MAP 70 mmHg

Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionmmHg*minute (Median)
Usual Care Group273
Hypotension Decision Support235

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Depth and Duration of Intraoperative Hypotension - Threshold MAP 75 mmHg

Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionmmHg*minute (Median)
Usual Care Group485
Hypotension Decision Support417

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Estimated Intraoperative Blood Loss

The estimated blood loss in mL during the surgical procedure (NCT02726620)
Timeframe: During the surgical procedure: an expected average of 2 hours

InterventionmL (Median)
Usual Care Group100
Hypotension Decision Support75

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In-hospital Mortality

Hospital mortality rate during a single hospital admission after the surgery (NCT02726620)
Timeframe: All postoperative days during a single hospital admission, expected median of 5 days

InterventionParticipants (Count of Participants)
Usual Care Group487
Hypotension Decision Support137

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Incidence of a MAP < 50 mmHg

Incidence of a mean arterial pressure (MAP) < 50 mmHg during anesthesia for 1 minute or more. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionParticipants (Count of Participants)
Usual Care Group7781
Hypotension Decision Support2196

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Incidence of a MAP < 50 mmHg for > 10 Minutes

Incidence of a mean arterial pressure (MAP) < 50 mmHg for a cumulative duration of all hypotensive episodes of more than 10 minutes during the anesthetic phase of the procedure. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionParticipants (Count of Participants)
Usual Care Group1159
Hypotension Decision Support326

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Incidence of a MAP < 50 mmHg for > 20 Minutes

Incidence of a mean arterial pressure (MAP) < 50 mmHg for a cumulative duration of all hypotensive episodes of more than 20 minutes during the anesthetic phase of the procedure. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionParticipants (Count of Participants)
Usual Care Group304
Hypotension Decision Support85

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Incidence of a MAP < 55 mmHg

Incidence of a mean arterial pressure (MAP) < 55 mmHg during anesthesia for 1 minute or more. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionParticipants (Count of Participants)
Usual Care Group10991
Hypotension Decision Support3045

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Incidence of a MAP < 55 mmHg for > 10 Minutes

Incidence of a mean arterial pressure (MAP) < 55 mmHg for a cumulative duration of all hypotensive episodes of more than 10 minutes during the anesthetic phase of the procedure. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionParticipants (Count of Participants)
Usual Care Group3181
Hypotension Decision Support759

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Percentage of Responders for PPT at Each Time Point

Assessments will be made over a period of one hour, with assessments at 1 minute intervals for the first 5 minutes and then every 5 minutes after that. (NCT02908620)
Timeframe: Time of application up to one hour post-application

,,,
InterventionParticipants (Count of Participants)
Responded to treatment at the 1 minute time pointResponded to treatment at the 2 minute time pointResponded to treatment at the 3 minute time pointResponded to treatment at the 4 minute time pointResponded to treatment at the 5 minute time pointResponded to treatment at the 10 minute time pointResponded to treatment at the 15 minute time pointResponded to treatment at the 20 minute time pointResponded to treatment at the 25 minute time pointResponded to treatment at the 30 minute time pointResponded to treatment at the 35 minute time pointResponded to treatment at the 40 minute time pointResponded to treatment at the 45 minute time pointResponded to treatment at the 50 minute time pointResponded to treatment at the 55 minute time pointResponded to treatment at the 60 minute time point
One Spray CTY-5339-A121312121058433110000
One Spray CTY-5339-CB1414128786442101010
One Spray CTY-5339-CB in Combination With One Spray CTY-5339-P1013108964212111111
Two Sprays CTY-5339-A1291112765656301100

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Duration of Anesthesia as Measured by Pin Prick Test (PPT) for One Spray CTY-5339-A Compared to One Spray CTY-5339-CB

"Evaluations were completed at 1-minute intervals for the first 5 minutes to capture onset of anesthesia. Starting at 5 minutes after drug administration, the PPT was done at 5 minute intervals up to the one hour time point. If there was no indication of anesthesia by 10 minutes, the subject was considered a treatment failure and the assessment of PPT was discontinued. In addition, once onset of anesthesia had occurred, if there was no longer any anesthesia at two consecutive evaluation time points from 10 minutes onward, the assessment of PPT was discontinued.~The PPT was assessed using a 90-mm, 26-gauge pencil-point spinal needle. At screening, 3 pin pricks were performed on each cheek. Pin pricks were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale (NRS). In order to be eligible for the study, for each cheek, subjects must have had a minimum score of 3 for the last 2 pin pricks, and one of those scores had to be 4 or higher." (NCT02908620)
Timeframe: Change in pain assessment from baseline (time of application) up to one hour post-application

Interventionminutes (Mean)
One Spray CTY-5339-A17.9
One Spray CTY-5339-CB16.4

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Duration of Anesthesia as Measured by Heat Sensation Threshold (QST Heat) for One Spray CTY-5339-A Compared to One Spray CTY-5339-CB

"Starting at 5 minutes after drug administration, the QST was done at 5 minute intervals up to the one hour time point. If there was no indication of anesthesia by 10 minutes, the subject was considered a treatment failure and the assessment of PPT was discontinued. In addition, once onset of anesthesia had occurred, if there was no longer any anesthesia at two consecutive evaluation time points from 10 minutes onward, the assessment of QST was discontinued.~The heat stimuli were delivered in 3 repetitions, with inter-stimulus intervals of 30s. The basal thermode temperature was set at a comfortable 35ºC. The rate at which the thermode heated up was set at 0.5ºC/s, while the rate at which it cooled down was set at 8ºC/s. The maximum thermode temperature was set at 51ºC. Heat sensation threshold was defined as the temperature at which the subjects first felt tingling, warmth, heat, or pain." (NCT02908620)
Timeframe: Change in temperature from baseline (time of application) up to one hour post-application

Interventionminutes (Mean)
One Spray CTY-5339-A44.6
One Spray CTY-5339-CB51.1

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Onset of Anesthesia for QST Heat

Assessments will be made over a period of one hour, with assessments at 1 minute intervals for the first 5 minutes and then every 5 minutes after that. (NCT02908620)
Timeframe: Time of application up to one hour post-application

InterventionMinutes (Mean)
One Spray CTY-5339-A3.1
Two Sprays CTY-5339-A1.9
One Spray CTY-5339-CB1.7
CTY-5339-CB 1 Spray + Placebo 1 Spray4.2

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Duration of Anesthesia as Measured by Pin Prick Test (PPT) for Two Sprays CTY-5339-A Compared to One Spray CTY-5339-CB in Combination With One Spray CTY-5339-P (Placebo)

"Assessments will be made over a period of one hour, with assessments at 1 minute intervals for the first 5 minutes and then every 5 minutes after that. Duration of effect was defined as the time (in minutes) from onset to treatment failure (i.e., for PPT, an assessment of Same/More pain, and for QST, the average heat temperature was greater than the average heat temperature at Baseline (non-treated cheek), up to the 60-minute time point (at two consecutive time points)." (NCT02908620)
Timeframe: Time of application up to one hour post-application

InterventionMinutes (Mean)
Two Sprays CTY-5339-A17.3
One Spray CTY-5339-CB in Combination With One Spray CTY-5339-P13.5

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Percentage of Responders for QST Heat at Each Time Point

Assessments will be made over a period of one hour, with assessments at 1 minute intervals for the first 5 minutes and then every 5 minutes after that. (NCT02908620)
Timeframe: Time of application up to one hour post-application

,,,
InterventionParticipants (Count of Participants)
Responded to treatment at the 5 minute time pointResponded to treatment at the 10 minute time pointResponded to treatment at the 15 minute time pointResponded to treatment at the 20 minute time pointResponded to treatment at the 25 minute time pointResponded to treatment at the 30 minute time pointResponded to treatment at the 35 minute time pointResponded to treatment at the 40 minute time pointResponded to treatment at the 45 minute time pointResponded to treatment at the 50 minute time pointResponded to treatment at the 55 minute time pointResponded to treatment at the 60 minute time point
One Spray CTY-5339-A1617151715141312139910
One Spray CTY-5339-CB18171817151417161210910
One Spray CTY-5339-CB in Combination With One Spray CTY-5339-P1513151414131212111098
Two Sprays CTY-5339-A181717151514121111121111

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Onset of Anesthesia for PPT

Assessments will be made over a period of one hour, with assessments at 1 minute intervals for the first 5 minutes and then every 5 minutes after that. (NCT02908620)
Timeframe: Time of application up to one hour post-application

InterventionMinutes (Mean)
One Spray CTY-5339-A1.2
Two Sprays CTY-5339-A1.5
One Spray CTY-5339-CB1.7
One Spray CTY-5339-CB in Combination With One Spray CTY-5339-P1.7

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Duration of Anesthesia as Measured by QST Heat for Two Sprays CTY-5339-A Compared to One Spray CTY-5339-CB in Combination With One Spray CTY-5339-P (Placebo)

"Assessments will be made over a period of one hour, with assessments at 1 minute intervals for the first 5 minutes and then every 5 minutes after that. Duration of effect was defined as the time (in minutes) from onset to treatment failure (i.e., for PPT, an assessment of Same/More pain, and for QST, the average heat temperature was greater than the average heat temperature at Baseline (non-treated cheek), up to the 60-minute time point (at two consecutive time points)." (NCT02908620)
Timeframe: Time of application up to one hour post-application

Interventionminutes (Mean)
Two Sprays CTY-5339-A46.8
One Spray CTY-5339-CB in Combination With One Spray CTY-5339-P38.9

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Duration of Anesthesia as Measured by QST Heat for One Spray CTY-5339-A Compared to Two Sprays CTY-5339-A

Assessments will be made over a period of one hour, with assessments at 1 minute intervals for the first 5 minutes and then every 5 minutes after that. (NCT02908620)
Timeframe: Time of application up to one hour post-application

Interventionminutes (Mean)
One Spray CTY-5339-A44.6
Two Sprays CTY-5339-A46.8

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Duration of Anesthesia as Measured by PPT for One Spray CTY-5339-A Compared to Two Sprays CTY-5339-A

Assessments will be made over a period of one hour, with assessments at 1 minute intervals for the first 5 minutes and then every 5 minutes after that. (NCT02908620)
Timeframe: Time of application up to one hour post-application

Interventionminutes (Mean)
One Spray CTY-5339-A17.9
Two Sprays CTY-5339-A17.3

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Stage I: Onset of Anesthesia for Heat Sensation Threshold (QST Heat)

"Onset of anesthesia was defined by Pin Prick Test (PPT) unless specific QST thresholds were not met.~If the PPT Onset was 5 minutes or less, then QST must have been greater than the Baseline QST temperature at 5 minutes by any amount and QST must have been ≥ 3 °C of the Baseline QST at 5 or 10 minutes.~If the PPT Onset was 10 minutes, then QST must have been ≥ 3 °C of the Baseline QST temperature at 10 minutes.~If PPT did not achieve Onset, then QST alone could have achieved onset at either 5 or 10 minutes if QST was greater than the Baseline QST temperature at 5 or 10 minutes by any amount and the QST was ≥ 3 °C of the Baseline QST at 5 or 10 minutes.~QST Heat scores were the temperature where the sensation of a heat stimuli was felt: ranging from 35 ºC to a maximum of 50.5 ºC with intervals of 0.5 ºC, at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point.~Stage I outcome." (NCT03233737)
Timeframe: Up to one hour post-application

Interventionminutes (Mean)
Stage I: One Spray CTY-5339-A2.0
Stage I: One Spray CTY-5339-CB0.4
Stage I: One Spray CTY-5339-P0.8

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Stage I: Onset of Anesthesia for Pin Prick Test (PPT)

"Onset of anesthesia was the time point at which the PPT average pain score was less than the Baseline PPT average score by any amount. Also, in 10 minutes or less, the subject must have had a lower PPT average pain score of ≥ 1 unit than the Baseline PPT. Onset was expected to be between 1 and 5 minutes. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point.~Stage I outcome." (NCT03233737)
Timeframe: Up to one hour post-application

Interventionminutes (Mean)
Stage I: One Spray CTY-5339-A1.3
Stage I: One Spray CTY-5339-CB1.2
Stage I: One Spray CTY-5339-P2.8

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Stage I: Percentage of Subjects Reaching Maximum Heat for Heat Sensation Threshold (QST Heat)

"QST Heat scores were the temperature where the sensation of a heat stimuli was felt: ranging from 35 ºC to a maximum of 50.5 ºC with intervals of 0.5 ºC, at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. Reaching maximum heat for QST Heat was defined as subjects reaching the maximum temperature without reporting pain at one or more time points.~Stage I outcome." (NCT03233737)
Timeframe: Any time within one hour post-application

InterventionParticipants (Count of Participants)
Stage I: One Spray CTY-5339-A5
Stage I: One Spray CTY-5339-CB0
Stage I: One Spray CTY-5339-P0

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Stage I: Percentage of Subjects Reaching Minimal Pain on Pin Prick Test (PPT) (≤2 on Numerical Rating Scale Pain Scale)

"Response is defined as a subject having a PPT average pain score of ≤2 recorded at any single time point where PPT was performed. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point.~Stage I outcome." (NCT03233737)
Timeframe: Any time within one hour post-application

InterventionParticipants (Count of Participants)
Stage I: One Spray CTY-5339-A10
Stage I: One Spray CTY-5339-CB9
Stage I: One Spray CTY-5339-P2

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Stage II: Duration of Anesthesia as Measured by Heat Sensation Threshold (QST Heat) for One Spray CTY-5339-A Compared to One Spray CTY-5339-CB

"The duration of effect, was defined as the time from onset to treatment failure, as measured by QST Heat score. QST Heat scores were the temperature where the sensation of a heat stimuli was felt: ranging from 35 ºC to a maximum of 50.5 ºC with intervals of 0.5 ºC, at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. The QST Heat-based Duration of effect was calculated by the length of time in minutes from onset of anesthesia to the absence of anesthesia where Onset of anesthesia was defined by PPT unless specific QST thresholds were not met. After Onset had been established, absence of analgesia or offset was the first of two time points with consecutive occurrences of regression or absence of analgesia. Reports of QST heat pain temperature by ≥ 3 °C of the Baseline QST indicated analgesia; while a report of similar (<3 °C) than Baseline indicated regression or absence of analgesia. Stage" (NCT03233737)
Timeframe: Up to one hour post-application

Interventionminutes (Mean)
One Spray CTY-5339-A45.5
One Spray CTY-5339-CB40.8

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Stage II: Duration of Anesthesia as Measured by Pin Prick Test (PPT) for One Spray CTY-5339-A Compared to One Spray CTY-5339-CB

"The duration of effect, was defined as the length of time in minutes from onset of anesthesia to the absence of anesthesia.Onset was the time point at which the PPT average pain score was less than the Baseline PPT average score by any amount. Also, in 10 minutes or less, the subject must have had a lower PPT average pain score of ≥ 1 unit than Baseline. Absence of anesthesia was defined as follows: After Onset had been established, absence was the first of two time points with consecutive occurrences of regression of absence of analgesia. Reports of less pain by ≥1 unit than Baseline indicated analgesia; while a report of similar (< 1 unit) or more pain than Baseline indicated regression or absence of analgesia. The minimum onset time was 1 minute. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point.~Stage II outcome." (NCT03233737)
Timeframe: Up to one hour post-application

Interventionminutes (Mean)
One Spray CTY-5339-A14.6
One Spray CTY-5339-CB7.4

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Stage II: Duration of Minimal Pain for Pin Prick Test (PPT) (≤2 on Numerical Rating Scale Pain Scale)

"Response at a time point is defined as having the PPT average pain score of ≤2. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point.~Stage II outcome." (NCT03233737)
Timeframe: Up to one hour post-application

Interventionminutes (Mean)
One Spray CTY-5339-A14.6
One Spray CTY-5339-CB7.4

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Stage II: Percentage of Subjects Reaching Maximum Heat for Heat Sensation Threshold (QST Heat)

"QST Heat scores were the temperature where the sensation of a heat stimuli was felt: ranging from 35 ºC to a maximum of 50.5 ºC with intervals of 0.5 ºC, at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. Reaching maximum heat for QST Heat was defined as subjects reaching the maximum temperature without reporting pain at one or more time points.~Stage II outcome." (NCT03233737)
Timeframe: Any time within one hour post-application

InterventionParticipants (Count of Participants)
One Spray CTY-5339-A7
One Spray CTY-5339-CB5

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Stage II: Onset of Anesthesia for Pin Prick Test (PPT)

"Onset of anesthesia was the time point at which the PPT average pain score was less than the Baseline PPT average score by any amount. Also, in 10 minutes or less, the subject must have had a lower PPT average pain score of ≥ 1 unit than the Baseline PPT. Onset was expected to be between 1 and 5 minutes. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point.~Stage II outcome." (NCT03233737)
Timeframe: Up to one hour post-application

Interventionminutes (Mean)
One Spray CTY-5339-A1.1
One Spray CTY-5339-CB1.1

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Stage II: Percentage of Subjects Reaching Minimal Pain on Pin Prick Test (PPT) (≤2 on Numerical Rating Scale Pain Scale)

"Response is defined as a subject having a PPT average pain score of ≤2 recorded at any single time point where PPT was performed. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point.~Stage II outcome." (NCT03233737)
Timeframe: Any time within one hour post-application

InterventionParticipants (Count of Participants)
One Spray CTY-5339-A50
One Spray CTY-5339-CB50

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Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point

"Response at a time point is defined as an increase of QST heat pain temperature by ≥ 3 degrees C compared to the Baseline QST. QST Heat scores were the temperature where the sensation of a heat stimuli was felt: ranging from 35 ºC to a maximum of 50.5 ºC with intervals of 0.5 ºC, at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point.~Stage I outcome." (NCT03233737)
Timeframe: Time of application up to one hour post-application

,,
InterventionParticipants (Count of Participants)
Responded to treatment at the 1 minute time pointResponded to treatment at the 2 minute time pointResponded to treatment at the 3 minute time pointResponded to treatment at the 4 minute time pointResponded to treatment at the 5 minute time pointResponded to treatment at the 10 minute time pointResponded to treatment at the 15 minute time pointResponded to treatment at the 20 minute time pointResponded to treatment at the 25 minute time pointResponded to treatment at the 30 minute time pointResponded to treatment at the 35 minute time pointResponded to treatment at the 40 minute time pointResponded to treatment at the 45 minute time pointResponded to treatment at the 50 minute time pointResponded to treatment at the 55 minute time pointResponded to treatment at the 60 minute time point
Stage I: One Spray CTY-5339-A7788899998666666
Stage I: One Spray CTY-5339-CB2333332211100000
Stage I: One Spray CTY-5339-P4444444410000000

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Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point

"Response at at time point is defined as when the PPT average pain score was less than the Baseline PPT average score by any amount. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point.~Stage I outcome." (NCT03233737)
Timeframe: Time of application up to one hour post-application

,,
InterventionParticipants (Count of Participants)
Responded to treatment at the 1 minute time pointResponded to treatment at the 2 minute time pointResponded to treatment at the 3 minute time pointResponded to treatment at the 4 minute time pointResponded to treatment at the 5 minute time pointResponded to treatment at the 10 minute time pointResponded to treatment at the 15 minute time pointResponded to treatment at the 20 minute time pointResponded to treatment at the 25 minute time pointResponded to treatment at the 30 minute time pointResponded to treatment at the 35 minute time pointResponded to treatment at the 40 minute time pointResponded to treatment at the 45 minute time pointResponded to treatment at the 50 minute time pointResponded to treatment at the 55 minute time pointResponded to treatment at the 60 minute time point
Stage I: One Spray CTY-5339-A8910101010101099987766
Stage I: One Spray CTY-5339-CB810101010108442211111
Stage I: One Spray CTY-5339-P4333233222222222

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Stage I: Sum of Pain Intensity Differences (SPID) for Pin Prick Test (PPT) (Post-hoc)

"SPID was calculated as a sum of the delta PPT scores at each time point until the designated time point. The delta PPT score is defined as the change in PPT score from baseline. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point.~The total possible scale range was from -100 (best) to +100 (worst) for SPID at the 30 minute time point, and from -160 (best) to +160 (worst) for SPID at the 60 minute time point Lower scores signify a better outcome (less sensitive to pain than at baseline = less pain with therapy = therapy was more effective).~Stage I outcome." (NCT03233737)
Timeframe: Up to one hour post-application

,,
Interventionscore (Mean)
SPID at the 30 minute time pointSPID at the 60 minute time point
Stage I: One Spray CTY-5339-A-82.1-128.1
Stage I: One Spray CTY-5339-CB-37.8-44.0
Stage I: One Spray CTY-5339-P-29.3-53.3

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Stage I: Sum of Temperature Differences (STID) for Heat Sensation Threshold (QST Heat) (Post-hoc)

"STID was calculated as a sum of the delta QST Heat scores at each time point until the designated time point. The delta QST Heat score is defined as the change in QST Heat score from baseline. QST Heat scores were the temperature where the sensation of a heat stimuli was felt: ranging from 35 ºC to a maximum of 50.5 ºC with intervals of 0.5 ºC, at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point.~The total possible scale range was from -155 ºC (best) to +155 ºC (worst) for STID at the 30 minute time point, and from -248 ºC (best) to +248 ºC (worst) for SPID at the 60 minute time point Lower scores signify a better outcome (less sensitive to pain than at baseline = less pain with therapy = therapy was more effective).~Stage I outcome." (NCT03233737)
Timeframe: Up to one hour post-application

,,
InterventionDegrees Celcius (ºC) (Mean)
STID at the 30 minute time pointSTID at the 60 minute time point
Stage I: One Spray CTY-5339-A153.0320.2
Stage I: One Spray CTY-5339-CB10.426.1
Stage I: One Spray CTY-5339-P72.5134.6

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Stage II: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point

"Response at a time point is defined as an increase of QST heat pain temperature by ≥ 3 degrees C compared to the Baseline QST.~QST Heat scores were the temperature where the sensation of a heat stimuli was felt: ranging from 35 ºC to a maximum of 50.5 ºC with intervals of 0.5 ºC, at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point.~Stage II outcome." (NCT03233737)
Timeframe: Up to one hour post-application

,
InterventionParticipants (Count of Participants)
Responded to treatment at the 1 minute time pointResponded to treatment at the 2 minute time pointResponded to treatment at the 3 minute time pointResponded to treatment at the 4 minute time pointResponded to treatment at the 5 minute time pointResponded to treatment at the 10 minute time pointResponded to treatment at the 15 minute time pointResponded to treatment at the 20 minute time pointResponded to treatment at the 25 minute time pointResponded to treatment at the 30 minute time pointResponded to treatment at the 35 minute time pointResponded to treatment at the 40 minute time pointResponded to treatment at the 45 minute time pointResponded to treatment at the 50 minute time pointResponded to treatment at the 55 minute time pointResponded to treatment at the 60 minute time point
One Spray CTY-5339-A36373737373838363228242219171413
One Spray CTY-5339-CB2930303031343129241915151212119

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Stage II: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point

"Response at at time point is defined as when the PPT average pain score was less than the Baseline PPT average score by any amount. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point.~Stage II outcome." (NCT03233737)
Timeframe: Up to one hour post-application

,
InterventionParticipants (Count of Participants)
Responded to treatment at the 1 minute time pointResponded to treatment at the 2 minute time pointResponded to treatment at the 3 minute time pointResponded to treatment at the 4 minute time pointResponded to treatment at the 5 minute time pointResponded to treatment at the 10 minute time pointResponded to treatment at the 15 minute time pointResponded to treatment at the 20 minute time pointResponded to treatment at the 25 minute time pointResponded to treatment at the 30 minute time pointResponded to treatment at the 35 minute time pointResponded to treatment at the 40 minute time pointResponded to treatment at the 45 minute time pointResponded to treatment at the 50 minute time pointResponded to treatment at the 55 minute time pointResponded to treatment at the 60 minute time point
One Spray CTY-5339-A47505049494949494846433632252019
One Spray CTY-5339-CB46484848494948464542342721202018

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Stage II: Sum of Pain Intensity Differences (SPID) for Pin Prick Test (PPT) (Post-hoc)

"SPID was calculated as a sum of the delta PPT scores at each time point until the designated time point. The delta PPT score is defined as the change in PPT score from baseline. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point.~The total possible scale range was from -100 (best) to +100 (worst) for SPID at the 30 minute time point, and from -160 (best) to +160 (worst) for SPID at the 60 minute time point Lower scores signify a better outcome (less sensitive to pain than at baseline = less pain with therapy = therapy was more effective).~Stage II outcome." (NCT03233737)
Timeframe: Up to one hour post-application

,
Interventionscore (Mean)
SPID at the 30 minute time pointSPID at the 60 minute time point
One Spray CTY-5339-A-85.2-122.6
One Spray CTY-5339-CB-63.2-86.6

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Stage II: Sum of Temperature Differences (STID) for Heat Sensation Threshold (QST Heat) (Post-hoc)

"STID was calculated as a sum of the delta QST Heat scores at each time point until the designated time point. The delta QST Heat score is defined as the change in QST Heat score from baseline. QST Heat scores were the temperature where the sensation of a heat stimuli was felt: ranging from 35 ºC to a maximum of 50.5 ºC with intervals of 0.5 ºC, at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point.~The total possible scale range was from -155 ºC (best) to +155 ºC (worst) for STID at the 30 minute time point, and from -248 ºC (best) to +248 ºC (worst) for SPID at the 60 minute time point Lower scores signify a better outcome (less sensitive to pain than at baseline = less pain with therapy = therapy was more effective).~Stage II outcome." (NCT03233737)
Timeframe: Up to one hour post-application

,
InterventionDegrees Celcius (ºC) (Mean)
STID at the 30 minute time pointSTID at the 60 minute time point
One Spray CTY-5339-A136.5214
One Spray CTY-5339-CB96.6149.1

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Stage II: Onset of Anesthesia for Heat Sensation Threshold (QST Heat)

"Onset of anesthesia was defined by Pin Prick Test (PPT) unless specific QST thresholds were not met.~If the PPT Onset was 5 minutes or less, then QST must have been greater than the Baseline QST temperature at 5 minutes by any amount and QST must have been ≥ 3 °C of the Baseline QST at 5 or 10 minutes.~If the PPT Onset was 10 minutes, then QST must have been ≥ 3 °C of the Baseline QST temperature at 10 minutes.~If PPT did not achieve Onset, then QST alone could have achieved onset at either 5 or 10 minutes if QST was greater than the Baseline QST temperature at 5 or 10 minutes by any amount and the QST was ≥ 3 °C of the Baseline QST at 5 or 10 minutes.~QST Heat scores were the temperature where the sensation of a heat stimuli was felt: ranging from 35 ºC to a maximum of 50.5 ºC with intervals of 0.5 ºC, at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point.~Stage II outcome." (NCT03233737)
Timeframe: Up to one hour post-application

Interventionminutes (Mean)
One Spray CTY-5339-A1
One Spray CTY-5339-CB1.3

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Stage I: Duration of Anesthesia as Measured by Heat Sensation Threshold (QST Heat) for One Spray CTY-5339-A Compared to One Spray CTY-5339-CB Compared to One Spray CTY-5339-P (Placebo: Vehicle Control)

"The duration of effect, was defined as the time from onset to treatment failure, as measured by QST Heat score. QST Heat scores were the temperature where the sensation of a heat stimuli was felt: ranging from 35 ºC to a maximum of 50.5 ºC with intervals of 0.5 ºC, at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. The QST Heat-based Duration of effect was calculated by the length of time in minutes from onset of anesthesia to the absence of anesthesia where Onset of anesthesia was defined by PPT unless specific QST thresholds were not met. After Onset had been established, absence of analgesia or offset was the first of two time points with consecutive occurrences of regression or absence of analgesia. Reports of QST heat pain temperature by ≥ 3 °C of the Baseline QST indicated analgesia; while a report of similar (<3 °C) than Baseline indicated regression or absence of analgesia. Stage I outcome." (NCT03233737)
Timeframe: Up to one hour post-application

Interventionminutes (Mean)
Stage I: One Spray CTY-5339-A42.5
Stage I: One Spray CTY-5339-CB6.1
Stage I: One Spray CTY-5339-P5

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Stage I: Duration of Anesthesia as Measured by Pin Prick Test (PPT) for One Spray CTY-5339-A Compared to One Spray CTY-5339-CB Compared to One Spray CTY-5339-P (Placebo: Vehicle Control)

"The duration of effect, was defined as the length of time in minutes from onset of anesthesia to the absence of anesthesia.Onset was the time point at which the PPT average pain score was less than the Baseline PPT average score by any amount. Also, in 10 minutes or less, the subject must have had a lower PPT average pain score of ≥ 1 unit than Baseline. Absence of anesthesia was defined as follows: After Onset had been established, absence was the first of two time points with consecutive occurrences of regression of absence of analgesia. Reports of less pain by ≥1 unit than Baseline indicated analgesia; while a report of similar (< 1 unit) or more pain than Baseline indicated regression or absence of analgesia. The minimum onset time was 1 minute. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point.~Stage I outcome." (NCT03233737)
Timeframe: Up to one hour post-application

Interventionminutes (Mean)
Stage I: One Spray CTY-5339-A49.2
Stage I: One Spray CTY-5339-CB21.3
Stage I: One Spray CTY-5339-P25.2

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Stage I: Duration of Minimal Pain for Pin Prick Test (PPT) (≤2 on Numerical Rating Scale Pain Scale)

"Response at a time point is defined as having the PPT average pain score of ≤2. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point.~Stage I outcome." (NCT03233737)
Timeframe: Up to one hour post-application

Interventionminutes (Mean)
Stage I: One Spray CTY-5339-A14.5
Stage I: One Spray CTY-5339-CB2.9
Stage I: One Spray CTY-5339-P0.2

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Neonatal Resuscitation Checklist

A 30 items checklist will be used. Each of the correct actions was graded as 1=yes and for wrong action 0=no. The total score ranged from 0 to 30. The total score ranged from 0 to 30. A higher score means have more skill. (NCT04748341)
Timeframe: before intervention and 6 weeks after intervention

,
Interventionscore on a scale (Mean)
Before intervention (pre data)6 weeks after intervention (post data)
Pedagogical Group3.3724.27
Traditional Group3.3016.20

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Self-efficacy for Neonatal Resuscitation (SENR)

The SENR instrument is a 23-item scale that measured nursing students' perception of confidence in their capabilities in neonatal resuscitation. All SENR items were valued on a 10-point Likert scale. The total score ranged from 0 to 230. A higher score means have more self-efficacy. (NCT04748341)
Timeframe: before intervention and 6 weeks after intervention

,
Interventionscore on a scale (Mean)
Before 6 weeks (pre data)After 6 weeks (Post data)
Pedagogical Group95.9188.6
Traditional Group96.1186.6

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Knowledge Questionnaire

knowledge is considering awareness of Neonatal resuscitation. It will be measured through a 17-item multiple-choice question adopted from Knowledge Question total score ranged from 0 to 17. A higher score means have more knowledge. (NCT04748341)
Timeframe: before intervention and 6 weeks after intervention

,
Interventionscore on a scale (Mean)
before 6 weeks (pre data)After 6 weeks (Post data)
Pedagogical Group5.8713.33
Traditional Group5.909.97

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