Triple Blind Randomised Control Trial of Two Different Treatment Analgesic Regimens Following Open Reduction and Internal Fixation of Mandibular ...
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International Journal of Research and Review
Vol.7; Issue: 3; March 2020
Website: www.ijrrjournal.com
Original Research Article E-ISSN: 2349-9788; P-ISSN: 2454-2237
Triple Blind Randomised Control Trial of Two
Different Treatment Analgesic Regimens Following
Open Reduction and Internal Fixation of
Mandibular Fractures
Sahana MS1, Nikhil N2, Gopalkrishnan K3
1
Lecturer, Department of Oral and Maxillofacial Surgery, D A P M R V Dental College and Hospital, Bangalore
2
Assistant Professor, 3Professor,
Department of Oral and Maxillofacial Surgery, SDM College of Dental Sciences and Hospital, Dharwad-
Karnataka
Corresponding Author: Sahana MS
ABSTRACT INTRODUCTION
Pain in trauma has a dual role. On
Aim: This study aims to compare two different one hand, pain is a good indicator to
analgesic drug regimens following open establish the severity and type of injury
reduction and internal fixation of mandibular whereas, on the other hand, pain can bring
fractures and to study the efficacy of the two
about severe complications and it may lead
drug regimens in post operative pain control.
Material and method: This study was to further worsening of the patient.
performed on 50 patients who were treated for Therefore, knowing how to control pain in
mandibular fractures by open reduction and patients is an important part of systemic
internal fixation under general anaesthesia at the approach to trauma.1
Department of Oral and Maxillofacial surgery in Pain after any surgical procedure is
SDM Craniofacial surgery and Research centre, anticipated and it is controlled by
Dharwad. The period of study was from administration of analgesics in most of the
November 2015 to July 2017. Subjects were cases. Causes of postoperative pain
divided into two groups i.e. Group 1 (received comprise surgical trauma, application of
Piroxicam) and Group 2 (received thermal and chemical stimuli to the wound,
Tramadol+Acetaminophen). The anaesthetist
and often traction and manipulation of soft
was in-charge and aware of the drugs prescribed
to the patient post-operatively. The Operating tissues.1
surgeon, the observer and statistician were Acute pain occurs as a consequence
blinded. of tissue damage either accidentally due to
Results: On the 1st and 2nd post operative days, an injury or as an outcome of
reduction in pain was assessed by means of surgery.2Greater than 80% of patients who
“Faces pain scale” a form of visual analog scale. go through surgical procedures experience
When comparing pain reduction in both the acute postoperative pain and approximately
groups, it was found to be more significant in 75% of the same describe the pain as mild,
patients belonging to Group 2 as compared to moderate, severe, or extreme3.
Group 1, i.e. a combination of Tramadol and Postoperative pain is an essential
Acetaminophen was found to be more
outcome in assessing overall treatment
efficacious.
success and patient contentment. High
Keywords: Mandibular fractures, Postoperative levels of acute postoperative pain have been
pain, Analgesics reported to be associated with slower
recovery of function, increased hospital
International Journal of Research and Review (ijrrjournal.com) 429
Vol.7; Issue: 3; March 2020Sahana MS et.al. Triple blind randomised control trial of two different treatment analgesic regimens following
open reduction and internal fixation of mandibular fractures
stay, and perioperative complications4.The
management of postoperative pain and The sample size has been estimated using
inflammation isa crucial component of the software GPower v. 3.1.9.4
patient care and are important for cost- Considering the effect size to be
effective use of healthcare resources. measured (d) at 80% for Two tailed
This triple blind randomized control hypothesis [Based on the results of previous
study highlights the importance of study done by Ankesh Dilip Jain et al,
management of postoperative pain using 2017], power of the study at 80% and the
two analgesics belonging to different groups margin of the error at 5%, the total sample
after open reduction and internal fixation in size needed was 50. So, each study group
patients with mandibular fractures. was comprised of 25 samples. [25 samples x
2 = 50 samples]
MATERIALS AND METHODS Inclusion criteria: ASA I, unilateral
This study was performed on 50 mandibular fractures not associated with
patients who were admitted to the any acute infection treated by intraoral
Department of Oral and Maxillofacial approach.
surgery in SDM Craniofacial surgery and Exclusion criteria: Patient with any
Research centre, Dharwad for treatment of systemic illness like cardiologic and
mandibular fractures by open reduction and neurologic disorders, patient with
internal fixation under general anaesthesia. pathologic fractures, osteoradionecrosis,
The period of study was from November strictly non-operable cases and other facial
2015 to July 2017, on patients who were fractures, paediatric mandibular fractures.
diagnosed with unilateral mandibular Subjects were divided into two groups i.e.
fractures and treated with ORIF using Group 1 (received Piroxicam: 20mg) and
intraoral approach. Group 2: received Tramadol+
Ethical approval: Clearance obtained from Acetaminophen (Tramadol 37.5mg +
Institutional Review Board. Acetaminophen 325mg). Both the drugs
IRB Number – 2015/P/OS/37 were administered orally.
CTRI TRAIL REGISTRATION NO.- The study was Triple-blinded as in-
CTRI/2018/02/012260 The Participant - The Patient
Sample Size Estimation The Investigator – Postgraduate trainee
The Administerer – The Nursing staff
Analysis: A priori: Compute required under the supervision of a constant
sample size Anaesthetist
Input: Tail(s) = Two The Operating surgeon was blinded as
Effect size d = 0.80 [Ankesh in, he was the person who only
Dilip Jain et al, 2017] performed the ORIF procedure, but not
α err prob = 0.05 aware of the drugs prescribed.
Power (1-β err prob) = 0.80
Allocation ratio N2/N1 = A constant anaesthetist was in-
1 charge of selecting the drug by
Output: Noncentrality parameter δ randomisation that is, by means of a
= 2.8844410 ‘Lottery dip method’ to eliminate any bias
Critical t = 2.0085591 during administration of the analgesics
Df = 48 prescribed to the patient post-operatively.
Sample size group 1 = 25 On the 1st and 2nd post operative days,
Sample size group 2 = 25 reduction in pain was assessed by means of
Total sample size = 50 “FACES PAIN SCALE”.
Actual power = 0.8074866
International Journal of Research and Review (ijrrjournal.com) 430
Vol.7; Issue: 3; March 2020Sahana MS et.al. Triple blind randomised control trial of two different treatment analgesic regimens following
open reduction and internal fixation of mandibular fractures
FACES PAIN SCALE- REVISED on Day 1 with a mean of 2.88 and also on
Statistical analysis: Data was collected and Day 2 with a mean of 0.16, ( p value= <
analysed using SPSS version 24. 0.001).
The pain reduction in each group has
RESULTS been explained separately in Table
Table 1 shows the age and gender 3(Piroxicam group) and Table 4,4a
incidence of 50 patients in both Group1 & (Tramadol+ Acetaminophen group) by
Group 2. After Mann Whitney test, the comparison of mean VAS scores at different
mean age group was found to range between time intervals in both the groups separately
20-55 years. After Chi square test, it was using Friedman’s test and Multiple
seen that male population was on the higher comparison of mean difference in vas scores
side in both the groups. between time intervals in both the groups,
Table 2 compares the mean VAS respectively.
scores between the 2 study groups at The statistical analysis concludes
different time intervals using Mann Whitney that there is significant pain reduction in
test. Significant pain reduction was noted in both the groups, but the patients belonging
patients belonging to Group 2 on both to group 2 had a significant pain relief on
POD1 & POD2. Patients belonging to POD 1 & POD 2 as compared to the
Group 2 showed significant pain reduction patients in group 1.
Table 1: Age & Gender distribution among the 2 study groups
Variables Category Piroxicam Tramazac P-Value
Mean SD Mean SD
Age Mean & SD 32.4 9.1 31.2 8.8 0.65a
Range 21 - 52 20 - 55
n % n %
Gender Males 20 80% 22 88% 0.44b
Females 5 20% 3 12%
a. Mann Whitney Test, b. Chi Square Test
Table 2: Comparison of mean VAS scores between 2 groups at different time intervals using Mann Whitney Test
Time Groups N Mean SD Mean Diff P-Value
Baseline Piroxicam 25 5.44 0.92 -0.16 0.51
Tramazac 25 5.60 0.82
POD1 Piroxicam 25 4.16 1.14 1.28 0.001*
Tramazac 25 2.88 1.30
POD2 Piroxicam 25 1.92 0.91 1.76Sahana MS et.al. Triple blind randomised control trial of two different treatment analgesic regimens following
open reduction and internal fixation of mandibular fractures
Table 3a: Multiple comparison of mean difference in VAS scores b/w time intervals in Piroxicam group using Wilcoxon Signed
Rank Post hoc Analysis
(I) Time (J) Time Mean Diff. (I-J) 95% CI for the Diff. P-Value
Lower Bound
Baseline POD1 1.28 0.78 1.78Sahana MS et.al. Triple blind randomised control trial of two different treatment analgesic regimens following
open reduction and internal fixation of mandibular fractures
better tolerated, and active ingredients for disease. Assessment of location and
short- and fast acting analgesics that act intensity of pain often suffices in clinical
through different pathways from opioids. It practice. However, other vital aspects of
is considered that the analgesic effects of acute pain, in addition to pain intensity at
Tramadol hydrochloride and rest, need to be clear and measured when
Acetaminophen are complementary and that clinical trials of acute pain treatment are
the combination may reduce the risk of considered14.
dose-dependent adverse drug reactions The visual analogue scale for pain
(ADRs) related to each ingredient without has been validated, premeditated
reducing the overall efficacy profile of the extensively, and verified to be a precise and
single agents.. A randomized controlled reliable measure of postoperative pain. The
clinical trial showed clear efficacy and a application of this scale in trauma and
reliable safety profile of Tramadol and surgical studies from other disciplines
Acetaminophen combination12. attests to its strength.15
In the present study, there is In our study, the ‘FACES PAIN
preponderance of males in both the groups, SCALE’ a part of the VAS has been used
which is quite unique like some of the for the assessment of post-operative pain.
previous studies by Natu et al5 in 2012 Cartoon-type faces pain scale, widely used
which showed a ratio of 4.5:1 whereas, in paediatric patients, has been suggested as
Malik et al 6 in 2013 showed a ratio of the possible options for measuring pain
2.9:1, another study by Jain et al1 in 2016 intensity in adults. Validity of faces pain
showed a ratio of 5.6:1. Also, Barde et al7 in scale is supported by research reporting that
2017 showed a ratio of 3.7:1. A higher people from various cultures identify facial
overall frequency of mandibular fractures in expressions16.
this study was observed more in men as On comparing the post operative
compared to women which may be pain reduction, among the study groups
explained by the fact that men are more (Group 1 and Group 2) with respect to pain
exposed to certain risk situations, such as, at POD 1 and POD 2, significant pain
more male drivers on the roads, more likely reduction was seen in Group 2 patients who
to practice contact sports, prevalence of got a combination of Tramadol+
consumption of alcohol especially in a Acetaminophen as the postoperative
social setup like pub and bars, which very analgesic on both the days.
often may result in brawls and interpersonal
violence13. CONCLUSION
The most common age group of Hence, we come to a conclusion that
occurrence was found to be around 20-55 even though both the drugs were observed
years among all the patients in our study. to be equally efficient in controlling the
Similar studies done by Natu et al5 in 2012 post-operative pain, combination of
and Barde et al7 in 2017 showed 21- 30 Tramadol+ Acetaminophen was found to be
years as the most common age of more efficacious than Piroxicam.
occurrence, whereas Malik et al6 in 2013
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