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Original Research Article
Indian Journal of Pharmacy and Pharmacology, July-September, 2019;6(3):
Efficacy of prophylactic nasal drops of oxymetazoline versus ephedrine in reducing the
incidence of bleeding following nasotracheal intubation
Yassin Eltahir Awad Gassim1, Hadab. A. Mohamed2, Sireesha Bala3, Sateesh Arja4, Tarig Fadlallah Altahir Ahmed5*,
Alaa Khedir Omer Altahir6, Sahar M Elhadi7
1-3,5-7Professor, 4Dean, 1Omdurman Islamic University, Faculty of Medicine, Sudan, 2University of Khartoum, Faculty of Medicine, Sudan,
3-6Avalon University, School of Medicine, Ohio, 7University of Khartoum, Faculty of Dentistry, Sudan
*Corresponding Author: Tarig Fadlallah Altahir Ahmed
Email: tarig.ahmed@avalonu.org
Abstract
Introduction: Nasotracheal intubation (NTI) is the method of choice when orotracheal intubation is not feasible (Patients with limited
mouth opening), where orotracheal intubation is predicted to be difficult and in patients having airway related mechanical issues
(angioedema, Ludwig’s angina, tongue haematomas, jaw fracture etc.).
A common problem facing anaesthetist while performing nasotracheal intubation is bleeding which might affect the course of intubation,
surgery and recovery of the patient.
Oxymetazoline is a selective α1 and a partial α2 adrenergic receptors agonist. Since vascular beds widely express α1 receptors, the action
of oxymetazoline results in vasoconstriction.
Aims: To evaluate and compare the effect of using prophylactic nasal drops of oxymetazoline versus ephedrine on the incidence of nasal
bleeding when nasotracheal intubation is performed.
Materials and Methods: This interventional randomized single blinded controlled study was conducted in Khartoum Dental Hospital
during the period from September to October 2017. Sixty patients undergoing dental surgery were selected and were randomly assigned
into two groups to receive either oxymetazoline 0.05% nasal drops (30 patients) or 1 ml of Ephedrine 1% nasal drops (30 patients) 5
minutes before induction. The incidence and severity of epistaxis, the incidence of the commonest complications related to nasal bleeding
and the mode of recovery were assessed following NTI.
Data was collected through predesigned data collection sheet then analyzed using a statistical package for the social sciences and presented
as tables and figures.
Results: Among 60 participants, 53.3% had no bleeding with oxymetazoline application compared to 30% with those who used ephedrine.
Fair recovery was reported in 96.7% patients who received oxymetazoline compared to 63.3% from those who received ephedrine.
Complicated recovery was significantly more in patients who received ephedrine (36.7%)) compared to a single patient 3.3% from
oxymetazoline group.
Conclusion: the study concluded that patients undergoing NTI had no or minimal bleeding and lower rate of complications with the use of
oxymetazoline 0.5% compared to ephedrine nasal drops.
Keywords: Ephedrine, Oxymetazoline, Nasotracheal intubation, Nasal bleeding.
Introduction
Airway management in a complex task in maxillofacial
surgeries and patients with facial traumas. The choice of
intubation technique requires good assessment by a
multidisciplinary team that includes maxillofacial surgeons
and the anaesthesiologists; as well as good communication
between them.1 Nasotracheal intubation (NTI) is commonly
used in patients undergoing oral and maxillofacial surgery.2
NTI is the method of choice when orotracheal intubation is
not feasible (Patients with limited mouth opening), where
orotracheal intubation is predicted to be difficult and in
patients having airway related mechanical issues
(angioedema, Ludwig’s angina, tongue hematomas, jaw
fracture, etc.). Although nasal intubation is ideally done
using fiber-optic bronchoscope, blind nasal intubation
remains to have a distinctly valuable role in emergency
settings when fiber-optic bronchoscope is not available or
inappropriate because of excessive bleeding that
compromises visualization.
Although various complications resulting from NTI
were reported, e.g. turbinectomy and retropharyngeal
dissection, the most commonly encountered complication is
epistaxis.
Epistaxis can cause difficulty in intubation due to
obscured view during laryngoscopy, risk of blood aspiration
and problems of airway management following induction.
Epistaxis may occur as a result of direct nasal tissue
trauma, inexperienced intubator, poor quality rigid tubes or
increased fragility of the nasal mucosa. Several methods
have been postulated to reduce the incidence of epistaxis
during nasotracheal intubation e.g. topical vasoconstrictors
(epinephrine, phenylephrine, xylometazoline,
oxymetazoline, and cocaine), thermo-softening of the
nasotracheal tube, red rubber catheter etc.3
Oxymetazoline has been shown to induce pronounced
decongestion and vasoconstriction of the nasal mucosa that
lasts for 6-8 hours.4 It is a sympathomimetic agent with
marked alpha-adrenergic activity5 which is intended for
intranasal use. Oxymetazoline constricts the nasal blood
vessels, thereby decongesting the mucosa of the nose and
neighboring regions of the pharynx.
Ephedrine was first isolated in 1885.4 It is on the World
Health Organization’s List of Essential Medicines, the most
effective and safe medicines needed in a health system.5 The
wholesale cost in the developing countries is about 0.69 to
Yassin Eltahir Awad Gassim et al. Efficacy of prophylactic nasal drops of oxymetazoline versus ephedrine….
Indian Journal of Pharmacy and Pharmacology, July-September, 2019;6(3):
1.35 USD per dose.6 In the United States it is described as
being not expensive.7 It can normally be found in plants of
the Ephedra type.1
With the growing development of maxillofacial
surgery, the influence of NTI on the current practice can be
figured out by the fact that about 4112 operations, that
require the use of NTI, are annually performed in Khartoum
Dental Teaching Hospital.
Attempts to reduce the incidence of inadvertent
bleeding when using nasal route for intubation, contributes
greatly to the safety of anaesthetic practice and lessens the
complications encountered. The efficacy and cost
effectiveness of agents to be suitable for use as nasal
decongestion in our setting were the main motivations to
carry this study. For our knowledge, there were no previous
study done in Sudan assessing preemptive drug use for
prevention of nasal bleeding following NTI.
Materials and Methods
This interventional randomized single blinded controlled
study is designed to evaluate and compare the potential
effects of Oxymetazoline versus Ephedrine in preventing
nasal bleeding following NTI. In addition, the study
compares the incidence of common complications related to
nasal bleeding and the mode of patient’s recovery following
administration of either study drug.
This study took place at Khartoum Dental Teaching
Hospital in the period from September 2017 to October
2017. Khartoum Dental Teaching Hospital, being the main
dental hospital in the country, shoulders a huge bulk of
surgical workload.
Patient’s acceptance to be part of the study in addition
to, ASA grade 1 and 2 and elective surgeries performed
under general anesthesia using NTI were the main criteria
for inclusion in this study.
Patients who refuse to be part of the study, emergency
surgeries, patients having hypertension or ischemic heart
disease, patients receiving anticoagulants or having bleeding
diathesis, patients having allergy from the study drugs,
patients with American Society of Anesthesiologist (ASA)
physical status of >2 and patients with contraindications to
NTI (e.g. patients with basal skull fracture) were excluded
from the study.
Sixty patients, representing the total coverage of all
patients fulfilling the inclusion criteria during the study
period, were selected and were randomly assigned to one of
the two groups to receive either one ml of 0.05%
Oxymetazoline nasal drops (Oxy group, 30 patients) or 1 ml
of 1% Ephedrine nasal drops (Eph group, 30 patients) 5
minutes before induction of general anaesthesia.
Following a standard technique of anaesthesia to all
candidates of the study, NTI was performed by an expert
anaesthetists using Macintosh laryngoscope. The incidence
and severity of epistaxis, the incidence of the commonest
complications related to nasal bleeding (Laryngospasm,
disturbed laryngeal view and surgical field) and the quality
of recovery were assessed and reported by the researchers.
Data was collected using guided patient data form and
were analyzed using a master sheet, excel computer
programme and SPSS 16.0 version. Data was then presented
in figures and tables as appropriate. Hypotheses were tested
and 0.05 probability level was predetermined as the level of
significance.
An ethical approval was granted from the ethical
committee of Sudanese Medical Specialization Board
(SMSB) together with verbal and written consent from
patients enrolled in the study.
Results
The majority of patients in the study groups (43.3% of Oxy
group and 23.3% of Eph group) were aged < 20 years while
the rest were unequally distributed among all age ranges.
Fig. 1: Age distribution
As shown in fig. 2, the gender distribution was equal among the study groups. In either study group, the male gender
represented 63.3% (38 patients) while the female gender represented the remaining 36.7% (22 patients)).
Yassin Eltahir Awad Gassim et al. Efficacy of prophylactic nasal drops of oxymetazoline versus ephedrine….
Indian Journal of Pharmacy and Pharmacology, July-September, 2019;6(3):
Fig. 2: Gender distribution
On attempting NTI, the magnitude of the resultant nasal
bleeding was as follows (Table 1):
1.
16 patients (53.3%) had no bleeding when
Oxymetazoline was applied, compared to 9 patients
(30%) who received Ephedrine.
2.
Eight patients (26.7%) had minimal bleeding when
Oxymetazoline was applied compared to 11 patients
(36.7%) when Ephedrine was use.
3.
Patients who had moderate bleeding were 4 patients
(13.3%) in Oxy group, compared to 6 patients (20%) in
Eph group.
4.
The incidence of severe bleeding was significantly low
(P value <0.031) in both study groups (2 patients
(6.7%) of those who received Oxymetazoline and 4
patients (13.3%) for the Eph group).
Table 1: Distribution of patients according to the amount of bleeding
Amount of bleeding
Vasoconstrictor
Oxymetazoline
Ephedrine
N
%
N
%
Minimal
8
26.7
11
36.7
Moderate
4
13.3
6
20.0
Severe
2
6.7
4
13.3
No bleeding
16
53.3
9
30.0
Total
30
100.0
30
100.0
P value = 0.031
Regarding the quality of recovery (Table 2), fair recovery was reported in 29 (96.7%) patients who received Oxymetazoline
compared to 19 patients (63.3%) from those who received Ephedrine. Complicated recovery was significantly (P. value <
0.001) more in patients who received Ephedrine (11 patients (36.7%)) compared to a single patient (3.3%) from Oxy group).
Table 2: Distribution of the patients according to recovery
Recovery
Vasoconstrictor
Oxymetazoline
Ephedrine
N
%
N
%
Fair
29
96.7
19
63.3
Complicated
1
3.3
11
36.7
Total
30
100.0
30
100.0
P value = 0.001
Regarding the quality of recovery, the reported complications following NTI in patients receiving Ephedrine were either
Laryngospasm, disturbed laryngeal view and surgical field seen in 5 (45.4%) patients), laryngospasm in 3 patients (27.3%) or
both complications in 3 patients (27.3%). In comparison, the incidence of reported complication in the Oxy group were
significantly fewer (P value <0.033). The only one reported complication in this group was a single patient who developed
laryngospasm (Table 3).
Table 3: The incidence of postoperative complications
Yassin Eltahir Awad Gassim et al. Efficacy of prophylactic nasal drops of oxymetazoline versus ephedrine….
Indian Journal of Pharmacy and Pharmacology, July-September, 2019;6(3):
Complications
Vasoconstrictor
Oxymetazoline
Ephedrine
N
%
N
%
Laryngospasm
1
100.0
3
27.3
Disturbed surgical field
0
0.0
5
45.4
Laryngospasm + disturbed surgical field
0
0.0
3
27.3
Total
1
100.0
11
100.0
P value = 0.033
Discussion
Nasal bleeding following nasotracheal intubation is not an
uncommon complication.
This study is designed to evaluate and compare the
efficacy of prophylactic Oxymetazoline and Ephedrine nasal
drops in reducing the incidence of nasal bleeding following
nasotracheal route of intubation.
As derived from results of this study, the overall
incidence of nasotracheal tube-related complications were
noted to be less when Oxymetazoline nasal drops were used
before intubation. Premedication with Oxymetazoline
offered a significant reduction in the incidence of epistaxis.
A majority of patients who received Oxymetazoline had no
epistaxis following NTI compared to patients who received
Ephedrine nasal drops. The latter group showed a variable
degree of nasal bleed. Moreover, the preemptive
Oxymetazoline administration has significantly reduced the
possibility of complicated recovery. Our findings are
compatible with the results of Katz et al who compared the
alpha-adrenergic agonist oxymetazoline with cocaine and
lidocaine with epinephrine regarding prevention of epistaxis
following NTI. The nares of three groups of 14 patients each
were topically pretreated with 4% lidocaine with 1:100,000
epinephrine (group 1), 10% cocaine (group 2), or 0.05%
oxymetazoline (group 3) prior to NTI. After intubation,
epistaxis was estimated on a scale of 0 to 3, with 0
indicating no bleeding, 1 representing blood on the
nasotracheal tube only, 2 indicating blood pooling in the
pharynx, and 3 representing blood in the pharynx sufficient
to impede intubation. Only 29% of the patients in group 1
displayed no bleeding, whereas 57% of those in group 2 and
86% of those in group 3 had no bleeding. Nonparametric
analysis showed a statistically significant difference (p less
than 0.013) between oxymetazoline and lidocaine with
epinephrine.8
El-Seify et al tested the efficacy of prophylactic
intranasal admixture of xylometazoline and local anaesthetic
gel in reducing epistaxis after nasotracheal intubation in
children. They found that the incidence and severity of
bleeding were significantly reduced between the study
group (7.5%) compared with the control group (27.5%;
P<0.01). Navigability using fiber-optic bronchoscope was
similar in both groups. Admixture of intranasal
xylometazoline 0.1% drops and lidocaine 2% jelly reduced
the incidence and severity of epistaxis after NTI in
preschool children.9
In conclusion, the current study showed greater
efficiency of Oxymetazoline in preventing or reducing the
amount of epistaxis following nasotracheal intubation,
compared to Ephedrine. In addition, Oxymetazoline
significantly enhances the fairness of recovery associated
with nasal intubation compared to Ephedrine.
Postoperative complications were significantly less
noted with the preoperative use of Oxymetazoline compared
to Ephedrine nasal drops.
Source of funding
None.
Conflict of interest
None.
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How to cite this article: Gassim YEAH, Mohamed A,
Bala S, Arja S, Ahmed TFA, Altahir AKO, Elhadi SM.
Efficacy of prophylactic nasal drops of oxymetazoline
versus ephedrine in reducing the incidence of bleeding
following nasotracheal intubation. Indian J Pharm
Pharmacol 2019;6(3):
