World Journal of Pharmaceutical Research
Reshmina et al. SJIF Impact
World Journal of Pharmaceutical Factor 8.084
Research
Volume 9, Issue 7, 2120-2127. Research Article ISSN 2277– 7105
A COMPARATIVE STUDY OF PARACETAMOL VS DICLOFENAC
SODIUM FOR POST-OPERATIVE PAIN RELIEF IN LAPAROSCOPIC
APPENDECTOMY -STUDY AT A TERTIARY CARE CENTRE
Dr. Harshavardhan K.1, Dr. Rithesh D. Cunha2, Dr. Reshmina Chandni Clara
Dsouza3*, Dr. Paramanand Reddy4
1,2
Assistant Professor, MBBS, MD Anaesthesiology Department of Anaesthesiology, Father
Muller Medical College, FMMC, Kankanady, Mangalore Dakshina Kannada Karnataka
575002 India.
3
Associate Professor MBBS, Ms General Surgery Department of General Surgery, Father
Muller Medical College, Fmmc, Kankanady, Mangalore Dakshina Kannada Karnataka
575002 India.
4
Resident. MBBS, Anaesthesiology Department of Anaesthesiology, Father Muller Medical
College, FMMC, Kankanady, Mangalore Dakshina Kannada Karnataka 575002 India.
ABSTRACT
Article Received on
13 May 2020, Background and Objective: Appendicitis most often treated with a
Revised on 02 June 2020, combination of surgery and antibiotics. Although the magnitude of
Accepted on 23 June 2020,
pain can be expected to be reduced when compared to open
DOI: 10.20959/wjpr20207-17980
procedures, pain may still be a significant factor during the
postoperative recovery period following laparoscopic surgery.
*Corresponding Author
Recently paracetamol has been launched as an an injectable and is
Dr. Reshmina Chandni
popular as an postoperative analgesic as among surgeons. Diclofenac is
Clara Dsouza
Associate Professor MBBS, an acetic acid derivative non-steroidal anti-inflammatory with
Ms General Surgery analgesic properties These two drugs are cost-effective, easily
Department of General available, and also very few studies are available comparing these two
Surgery, Father Muller
drugs. In view of the above said we are conducted a study which
Medical College, Fmmc,
compared paracetamol 10 versus diclofenac 1.5 mg/kg IM for post-
Kankanady, Mangalore
Dakshina Kannada operative pain relief in laparoscopic appendectomy. Materials and
Karnataka 575002 India. Methods: After obtaining approval from hospital academics and ethics
committee prospective, randomized, double blind, comparative study
was conducted between the time period1st December 2018 to 30th march 2020 at father muller
medical college hospital. 100 consenting patients who underwent laparoscopic appendectomy
who met a pre-defined inclusion criteria and exclusion criteria were included the study and
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Reshmina et al. World Journal of Pharmaceutical Research
were assessed for the effects of diclofenac and paracetamol for post-operative pain
management. Each group received either paracetamol 10 mg/kg IV or diclofenac 1.5 mg/kg
IM. Visual analogue scale was explained to the patient preoperatively. Vital parameters was
checked and recorded preoperatively. Monitoring was done every 1 hourly for the first 3
hours and then every 6 hourly for next 24 hours. Results and Observations: The mean heart
rate, mean diastolic blood pressure, mean systolic blood pressure was more in the diclofenac
group suggesting that pain was observed more in the diclofenac group at all times, at all times
there was statistical significance with p value <0.05, pain was observed more in the
diclofenac group at all times, at all times there was statistical significance with p value <0.05
There was no significant changes in the two groups with respect to side effects with a p value
0.98. Conclusion: we found that both analgesic preparations that is paracetamol and
diclofenac were effective for postoperative pain relief and that paracetamol provided a similar
degree of pain relief to that of diclofenac but with lesser effects on the hemodynamics.
KEYWORDS: Analgesic, Paracetamol, Diclofenac.
INTRODUCTION
Appendicitis is a condition characterized by inflammation of the appendix. It is classified as a
medical emergency if untreated; mortality is high, mainly because of the risk of rupture
leading to peritonitis and shock.[1] Pain from appendicitis can be severe. Strong pain
medications are recommended for pain management.[2,3,4] Appendicitis most often treated
with a combination of surgery and antibiotics. The surgical procedure for removal of the
appendix is called an appendectomy. Often now the operation can be performed via a
laparoscopic approach, or open appendectomy method. Laparoscopic appendectomy is the
minimal invasive surgical procedure to treat the acute appendicitis, in which the abdominal
cavity is visualizing with the help of a laparoscope.[1]
Numerous advantages have been reported when comparing open versus minimally invasive
abdominal surgical procedures like the laparoscopy, including earlier return of bowel
function, decreased postoperative pain, quicker recovery, and earlier hospital discharge.[1,2]
Although the magnitude of pain can be expected to be reduced when compared to open
procedures, pain may still be a significant factor during the postoperative recovery period
following laparoscopic surgery. Without effective treatment, this ongoing pain may delay
recovery, mandate inpatient admission, and thereby increase the cost of such care. In addition
to pain at the incisional and trocar insertion sites, there may also be shoulder and diffuse
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abdominal pain. Shoulder pain and diffuse abdominal pain may be due to peritoneal
stretching and diaphragmatic irritation associated with carbon dioxide insufflation.[5,6]
Although in most circumstances pain is treated with an approach which uses parenteral
opioids and nonsteroidal anti-inflammatory agents combined with local infiltration of the
incisional sites, other novel techniques have been reported.[7,8]
Recently paracetamol has been launched as an an injectable and is popular as an
postoperative analgesic as among surgeons.[9,10]
Anirban Pal found that of injectable diclofenac intramuscularly (IM) s more effective than
injection paracetamol intravenously (IV) in terms of rescue analgesic requirement.[11]
Diclofenac is an acetic acid derivative non-steroidal anti-inflammatory and is available as a
generic drug in a number of formulations. Over the counter use is approved in some countries
for minor aches and pains and fever associated with common infections.[12]
These two drugs are cost-effective, easily available, and also very few studies are available
comparing these two drugs. In view of the above said we are conducted a study which
compared paracetamol versus diclofenac sodium for post-operative pain relief in laparoscopic
appendectomy.
MATERIALS AND METHODS
A prospective, randomized, double blind, comparative study was conducted between the time
period 1st December 2018 to 30th march 2020 at father muller medical college hospital. 100
consenting patients who underwent laparoscopic appendectomy who met a pre-defined
inclusion criteria and exclusion criteria were included the study and were assessed for the
effects of diclofenac and paracetamol for post-operative pain management.
The procedure of general anaesthesia was explained to the patient in their vernacular
language and written informed consent was taken. Preparation included an overnight fast of 8
hours before the surgery. Tablet Diazepam 10mg oral was given on the night prior to surgery.
Nil by mouth status was confirmed prior to surgery.
Patients were randomly divided into two groups according to computer generated
randomization table.
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GROUP A-received inj. diclofenac 1.5 mg/kg IM.
GROUP B-received inj. paracetamol 10 mg/kg IV.
The randomization was performed by a pharmacist who was not involved in the study. A
random number table was used for each treatment group, A or B(either paracetamol or
diclofenac) was allocated randomly, in to sealed trial samples numbered in keeping with the
randomization list.
Prospectively patients meeting the inclusion criteria for the trial were allocated randomly into
group A and group B. One group received diclofenac and the other received paracetamol. The
trial is so planned that neither the doctor nor the participant is aware of the group allocation
and the drug received.
Visual analogue scale was explained to the patient preoperatively.
Vital parameters was checked and recorded preoperatively.
Vital parameters was checked and recorded preoperatively. Monitoring was done every 1
hourly for the first 3 hours and then every 6 hourly for next 24 hours.
100 cases
50 cases received paracetamol 10 50 cases received paracetamol
mg/kg IV diclofenac 1.5 mg/kg IM
Figure 1: study consort chart.
The visual analogue scale (VAS), where intensity is ranged from 0-10 cm and 0 refers to “not
at all” and 10 indicates “worst imaginable”, was used to assess pain and anxiety.
Rating Pain Level
0 -4 mm No Pain
5 – 44 mm Mild Pain
45 – 74 mm Moderate Pain
75 – 100 mm Severe Pain
Figure 2: The visual analogue scale.
Adverse effects produced by the study drug such as nausea, vomiting, hypotension,
bradycardia, respiratory depression, muscle rigidity and laryngospasm were noted Data was
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compiled in MS Excel sheet. Data was analyzed using SPSS version 20th software. The
quantitative data was represented in form of mean, standard deviation, etc.
The qualitative data was represented in form of frequencies and percentage, also it was
represented on visual impression like bar diagram, pie diagram etc. To check the significant
difference between pain score of VAS between group A and group B, T-test was applied.
For qualitative data Chi-square test was applied. The significance was assessed at 5% level of
significance.
RESULTS AND OBSERVATIONS
In our study the mean age in the diclofenac and paracetamol group was 31.36 years and
in34.96 years with a p value 0.061 males predominated the study group all the cases in our
study were ASA 1 status, the mean weight in the diclofenac and paracetamol group was
53.36 years and in 54.96 years with a p value 0.052.
The mean heart rate, mean diastolic blood pressure, mean systolic blood pressure was more in
the diclofenac group suggesting that pain was observed more in the diclofenac group at all
times, at all times there was statistical significance with p value <0.05, pain was observed
more in the diclofenac group at all times, at all times there was statistical significance with p
value <0.05.
There was no significant changes in the two groups with respect to side effects with a p value
0.98.
DISCUSSION
Appendectomy is considered as the most common surgery that is performed by a surgeon,
with the advances that have occurred in the field of medicine with the amalgamation of
modern science and technology with medicine newer technologies like laparoscopic and
robotic surgery have been introduced, the aim of early return to work is the goal.
One of the most annoying feature to the patient and the surgeon is the post operative pain. As
the aim of minimally invasive surgeries is to reduce the days associated with disability and to
return to work early, it is of utmost importance that a good analgesia is provided in the
immediate postoperative period.
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One of the most important criteria for discharge from the postoperative ward is that patient is
pain free. The are many modalities that have been used in the management of pain in the post
operative period. till date the most common among them is the use of parenteral analgesics.
Though diclofenac is the most commonly used analgesic it itself has its own side effects
including predisposing to renal dysfunction, also it is not recommend for use in those who
have airway disease or chronic morbidities like diabetes, hypertension.
Recently paracetamol is been introduced in the intravenous form which has made way to use
for analgesia in the post operative period. The advantage is that it had lesser contradictions
for use as compared to diclofenace, which is the most commonly prescribed post operative
analgesia.[9,10]
Vinishdharma Thenarasu et al evaluated preumtive analgesia on twenty participants found
that those who were given Diclofenac had a higher analgesic effect and longer duration of
analgesia as compared to Paracetamol (500mg). However, the analgesic effect in patient
received Diclofenac is much more longer then patient received Paracetemol.[13]
Shashi Prakash et al evaluated post-operative analgesia following laparoscopic
cholecystectomy in two groups of patients received diclofenac with paracetamol p (100 ml
infusion) and patients received diclofenac with paracetamol pl (2 ml Stat and found that both
the group of patients have almost equal analgesic e وٴect and patient satisfaction, when drugs
were given as combination therapy in same dose.[14]
Mohamed Tawalbeh et al evaluated post-operative analgesia and found taht diclofenac
sodium has a significant effect on decreasing the pain associated with swallowing
postoperatively and on the general condition of the patient. Improved oral intake resulted in a
lower incidence of nausea and vomiting and allowed safer and earlier hospital discharge.[15]
To our knowledge our study is the first study to evaluate these two drugs alone without
placebo in laparoscopic appendectomy .hence we recommend that further larger studies abe
done on this.
CONCLUSION
We found that both analgesic preparations that is paracetamol and diclofenac were effective
for postoperative pain relief and that paracetamol provided a similar degree of pain relief to
that of diclofenac but with lesser effects on the hemodynamics.
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