Therapeutic
Intranasal Drug DeliveryFeatured new articles related to intranasal drug delivery:
October - December 2011
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Pestieau, S.R., et al., The effect of dexmedetomidine during myringotomy and pressure-equalizing tube placement in children. Paediatr Anaesth, 2011. 21(11): p. 1128-35.
BACKGROUND: Bilateral myringotomy (BMT) is a commonly
performed otolaryngologic procedure in children. OBJECTIVES: To examine
the effects of intranasal dexmedetomidine, an alpha(2)-adrenoceptor
agonist, on time-averaged pain scores, pain control, need for rescue
analgesia, and agitation scores in children undergoing BMT. METHODS: We
designed a trial to enroll 160 children randomized to one of four
groups: two study groups, dexmedetomidine (1 or 2 mug.kg(-1)), or two
control groups representing our institutional standards of practice
(intranasal fentanyl-2 mug.kg(-1) or acetaminophen as needed
postoperatively). RESULTS: After 101 children were enrolled, patient
caregivers observed that some enrollees were excessively sedated and
required prolonged postanesthesia care unit (PACU) stay. This
observation led to an unplanned interim analysis and early trial
termination. After data were collected, severe nonnormality of pain and
agitation scores necessitated a switch of the outcome to assess repeated
measurements of the proportion of patients with pain, severe pain, and
agitation. Demographics, time to emergence, and agitation were similar
among all groups. The risk of requiring acetaminophen rescue (P <
0.0001) and proportion of patients having pain (P = 0.016) was
significantly higher in one control group (rescue analgesia only)
compared with fentanyl or dexmedetomidine groups. Importantly, length of
stay in the PACU was significantly longer in dexmedetomidine-2
mug.kg(-1)-treated compared with dexmedetomidine-1 mug.kg(-1)-treated,
fentanyl-treated, or the control group, P = 0.0037. CONCLUSIONS: In this
trial, we were unable to answer the original question as to the role of
dexmedetomidine on time-averaged pain and agitation scores after BMT.
However, our findings clearly demonstrate that in children undergoing
BMT, at higher doses, dexmedetomidine significantly prolongs length of
stay in the PACU.
Web site Editorial comments:
These authors in fact did find that IN dexmedetomidine in either dose, or intranasal fentanyl at 2 mcg/kg was more effective at reducing postoperative pain and agitation than placebo. However, the high dose dexmedetomidine cases were in the recovery room much longer (70 minutes versus about 40 minutes). This article came out shortly after the comments we made in the July-Sept featured articles section related to IN dexmedetomidine in adults: "Despite this length of action there was no delay in recovery for this type of dental surgical extraction (perhaps this would not be the case for something fast like a myringotomy)." In fact this is exactly what the authors found. IN dexmedetomidine lasts so long (55 to 100 minutes per other articles by Yuen) that children undergoing myringotomy have a prolonged length of stay in the recovery room. the authors conclude that that intranasal fentanyl or rectal acetaminophen are also effective and do not result in longer recovery times so these therapies should be used for short surgical cases like myringotomy.
Pubmed link: http://www.ncbi.nlm.nih.gov/pubmed/21575102
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Antonio, C.,
J. Zurek, et al. (2011). "Reducing the pain of intranasal drug
administration." Pediatr Dent
33(5):
415-419.
PURPOSE: The purpose of this research study was to develop a score to
assess intranasal (IN) drug administration discomfort and then assess 3
different approaches to reduce the pain associated with the
administration of an IN citrate study solution. METHODS: After
Institutional Review Board approval and with informed consent,
volunteers intranasally received 0.3 M solution of citrate, on 4
different days. In stage 1, the citrate was administered via syringe or
by aerosol. Stage 2 compared the IN citrate before and 60 seconds after
2% lidocaine was given. Stage 3 compared the IN citrate to an IN mixture
of 2% lidocaine and citrate. A placebo of IN saline was also used on one
occasion. The degree of pain, burning, and unpleasant taste was recorded
using a scale of 1 to 10 to give an overall intranasal discomfort score
(INDS). RESULTS: The citrate proved significantly more unpleasant and
painful than the placebo saline. The mean INDS was 12.1, which was
significantly higher following IN citrate compared to saline. Lidocaine,
both pretreatment and mixed, significantly reduced the INDS.
CONCLUSIONS: The intranasal discomfort score appeared reproducible for
assessing painful intranasal drug administration. The addition of
lidocaine appeared to reduce the discomfort of intranasal citrate in
adult volunteers.
Web site Editorial comments:
This article is provided as an important article due to the concept of topical lidocaine to reduce nasal burning from irritating drugs. These authors found both pretreatment or simultaneous treatment with topical lidocaine (2%) was effective. Any time you consider nasal midazolam sedation in an awake child I suggest you utilize this concept to prevent the burning that occurs in the first minute.
Pubmed link: http://www.ncbi.nlm.nih.gov/pubmed/22104710
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Pandey, R. K., S. K. Bahetwar, et al. (2011). "A
comparative evaluation of drops versus atomized administration of
intranasal ketamine for the procedural sedation of young uncooperative
pediatric dental patients: a prospective crossover trial."
J Clin Pediatr Dent
36(1):
79-84.
OBJECTIVE: The objective of this study was to compare and evaluate the
efficacy and safety of drops and atomized administration of intranasal
ketamine (INK) in terms of behavioral response for agent acceptance
during administration and for agent efficacy and safety for the sedation
of young uncooperative pediatric dental patients. STUDY DESIGN:
Thirty-four uncooperative ASA grade-1 children, requiring dental
treatment were randomly assigned to receive INK as drops and atomized
spray in one of the subsequent visit. This was a two stage cross-over
trial and each child received INK by both modes of administration. The
vital signs were monitored continuously during each visit. RESULTS: A
statistically significant difference in patients acceptance (P < 0.0001)
was observed in the atomized administration when compared to drops
administration for the procedural event of drug administration. Moreover
there were also significant differences (P < 0.05) between onset of
sedation and recovery time between two groups. All the vital signs were
within normal physiological limits and there were no significant adverse
effects in either group. CONCLUSIONS: INK is safe and effective by
either mode of intranasal (IN) drug administration for moderate sedation
in facilitating dental care for anxious and uncooperative pediatric
dental patients. Moreover, INK when administered with the mucosal
atomization device, the acceptance of the drug was associated with less
aversive reaction, rapid onset and recovery of sedation, as compared to
the drop administration of the same agent.
Web site Editorial comments:
Interesting
article and another addition to our growing list of studies supporting
intranasal ketamine. Further evidence that we need to use ENOUGH drug or
it won’t work. This study confirms what others have also proven – that
we need doses of at least 5-6 mg/kg of nasal ketamine to achieve
moderate sedation (and if you read other studies carefully you need 9-10
mg/kg to achieve sedation deep enough to perform most truly painful
procedures). Another aspect
of this study was the crossover design to compare nasal drops to
atomization. Not surprising to those of us who have used nasal
medications for decades – the atomization group accepted nasal drug
delivery much more readily that the nasal drops - 70% excellent vs. 23%
excellent, 6% poor versus 44% poor.
Full article link (free access): Pandey 2011
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Title:
Abstract
Web site Editorial comments:
Pubmed link: