|Year : 2022 | Volume
| Issue : 3 | Page : 118-123
A comparison of intravenous paracetamol and intravenous paracetamol with dexmedetomidine for postoperative analgesia management in gynecological surgeries – A prospective randomized double-blinded study
A Srinithi, T Krishna Prasad, Rajarajeswaran Krishnan, S A. Senthil Kumar
Department of Anaesthesiology, Shri Sathya Sai Medical College and Research Institute, Chengalpattu, Tamil Nadu, India
|Date of Submission||31-Mar-2022|
|Date of Decision||30-Jun-2022|
|Date of Acceptance||26-Aug-2022|
|Date of Web Publication||25-Feb-2023|
Dr. T Krishna Prasad
Department of Anaesthesiology, Shri Sathya Sai Medical College and Research Institute, Ammapettai, Chengalpattu, Tamil Nadu
Source of Support: None, Conflict of Interest: None
Background: Substitution of nonopioid analgesic drugs in place of opioids perioperatively has become mandatory recently due to the development of the opioid crisis. This study emphasizes nonopioid alternatives to significantly reduce perioperative opioid consumption in gynecological surgeries.
Objective: This study compared the efficacy of intravenous paracetamol and intravenous (iv) paracetamol with dexmedetomidine in terms of postoperative visual analog scale (VAS) score, sedation score, hemodynamic changes, and analgesic requirement in gynecological procedures.
Materials and Methods: This prospective randomized double-blinded study included females between the age of 18 and 60 years who underwent gynecological surgeries. Group P received iv paracetamol 1 g infusion, Group DP received an infusion of iv paracetamol 1 g with dexmedetomidine at a dose of 0.5 μg/kg as infusion 10 min before the end of the surgery over 10 min. VAS score, sedation score, hemodynamic changes, and rescue analgesic requirement were observed up to 12 h postoperatively.
Results: Group DP had a significantly lower VAS score in the 4th and 6th h (P = 0.009 and 0.023, respectively). Group P had significantly higher rescue analgesia than Group DP (P = 0.005). Group DP had a significantly higher heart rate than Group P at the 2nd and 4th h (P = 0.001) postoperatively. Group DP had significantly lower mean arterial pressure than Group P at 2 h (P = 0.001). Sedation score among Group DP was significantly higher till 10 h.
Conclusion: Combining iv dexmedetomidine and paracetamol effectively reduces postoperative pain, analgesic requirements with good sedation score, and mild hemodynamic changes. Hence, it effectively increases postoperative comfort and reduces hospital stay and cost.
Keywords: Dexmedetomidine, gynecological surgeries, paracetamol, postoperative pain
|How to cite this article:|
Srinithi A, Prasad T K, Krishnan R, Kumar S A. A comparison of intravenous paracetamol and intravenous paracetamol with dexmedetomidine for postoperative analgesia management in gynecological surgeries – A prospective randomized double-blinded study. J Med Soc 2022;36:118-23
|How to cite this URL:|
Srinithi A, Prasad T K, Krishnan R, Kumar S A. A comparison of intravenous paracetamol and intravenous paracetamol with dexmedetomidine for postoperative analgesia management in gynecological surgeries – A prospective randomized double-blinded study. J Med Soc [serial online] 2022 [cited 2023 Mar 28];36:118-23. Available from: https://www.jmedsoc.org/text.asp?2022/36/3/118/370598
| Introduction|| |
Adequate and satisfactory pain control is one of the major concerns in anesthetic practice, especially in the postoperative period. Along with pain control, good sedation and smooth recovery without complication results in better patient satisfaction, shorter hospital stays, and reduced healthcare cost., Increased opioid usage for good control of postoperative pain results in unwanted complications such as respiratory depression, nausea and vomiting, increased sedation, and slow gastrointestinal functioning.
The nonopioid drugs can be used as an adjuvant to opioids or as sole agents, for an effective reduction in the need for further opioid doses. Adjuvants such as dexamethasone, alpha-2 agonists (clonidine and dexmedetomidine), magnesium, midazolam, buprenorphine, and NMDA-antagonists are administered alongside the opioids and local anesthetic agents as it exerts a synergistic action during and after the procedure for better and prolonged analgesic effect.
Paracetamol is a preeminent analgesic, known for its safety and better tolerance. Intravenous (iv) paracetamol provides a rapid and predictable therapeutic concentration in plasma. In 2010, Food and Drug Administration approved paracetamol iv infusion as a first-line drug for the management of mild to moderate pain and as an adjuvant for moderate to severe pain. It can be used as adjuvants that work synergistically with anesthetics to help enhance the duration and quality of analgesia in regional techniques.
Dexmedetomidine is a highly selective alpha-2 receptor agonist, which is eight times more specific compared to clonidine. Dexmedetomidine binds to the G-protein coupled with the alpha-2 receptors and generates the required clinical outcomes. Sedation occurs due to action on the locus coeruleus.
The pain score was significantly lower with good patient satisfaction in terms of hemodynamic changes, amount of opioid use, complications, and sedation scale. Many studies compared similar groups of drugs, but none compared the drug combination in gynecological surgeries, which helps in the first anesthetic requirement and avoiding opioids.
In this study, we aimed to compare the efficacy (postoperative pain score, time for the first analgesic requirement, hemodynamic changes, and sedation score) of iv paracetamol and iv paracetamol with dexmedetomidine in postoperative pain relief for patients undergoing gynecological surgeries.
| Materials and Methods|| |
This was a prospective, randomized, double-blinded study conducted on female patients 18–60 years of age of American Society of Anesthesiologists-I, II criteria who underwent total abdominal hysterectomy, vaginal hysterectomy, transabdominal tubectomy, fractional curettage, puerperal sterilization, and ovarian cystectomy. After obtaining Institutional Ethical Committee clearance (IEC.NO.2019/565), CTRI registration was done (CTRI/2020/02/023178). This study was carried out in a tertiary care center in Chengalpattu, for over 10 months. A total of 62 cases were allocated into two groups Group P and Group DP with 31 in each group by computerized randomization technique. Group P received i.v paracetamol as 1 g infusion 10 min before the end of the surgery over 10 min. Group DP was receiving a combination of iv paracetamol as a 1 g infusion and iv dexmedetomidine at a dose of 0.5 μg/kg as infusion 10 min before the end of the surgery over 10 min. One anesthesiologist performed the study while the other anesthesiologist recorded and evaluated the data, which was done to blind the group allocation. The procedure was explained to all patients in their mother tongue and informed valid consent was obtained. Those patients who refused for participating or with a history of allergy to paracetamol, dexmedetomidine, body mass index (BMI) <18 or >30 kg/m2, coagulopathy, poorly controlled diabetes mellitus, or hypertension were excluded from the study. All patients were monitored with planet 60/star 60 monitor, SANKRAY Technologies Pvt. Ltd, India.
After shifting the patients to the operation theater (OT), noninvasive monitors and Regional Anesthesia (Subarachnoid Block) were performed by OT anesthesiologists as per requirement and patient's acceptance with 0.5% bupivacaine (heavy) without additives. Surgery commenced and 10 min before the completion of surgery, the respective OT anesthesiologist gave the study drug following which the patient was shifted to the recovery room and monitored for 1 h. Then, the patient was shifted to postoperative ward.
Postoperative pain was assessed using the Visual Analog Scale regularly every 2 h up to 12 h postoperatively by an observer (anesthesiologist) who was also blinded. Rescue analgesic drug was intramuscular ketorolac if VAS ≥4/10. Hemodynamic changes along with time and requirement of rescue analgesia and sedation score were also assessed and documented. The incidence of side effects such as bradycardia, hypotension, and sedation was documented. The sedation score was assessed according to the modified Ramsay Sedation Scale. Heart rate fall 20% from the baseline value or and if it was <50 beats/min was managed by a 0.5 mg iv bolus of atropine. A fall in blood pressure by 20% from the baseline or a mean arterial pressure (MAP) <60 mmHg was managed with crystalloids (200 ml of ringer lactate/normal saline) or increments of iv mephentermine 3 mg.
According to a previous study, considering the mean and standard deviation (SD) of visual analog score among the paracetamol group as 2.07 ± 0.35, the mean and SD of visual analog score among the paracetamol + dexmedetomidine group was 2.33 ± 0.43 at 95% confidence interval with 80% power. A sample size of 31 in each group.
Variables are represented in frequencies and percentages. Inferential statistics is depicted as when a numerical variable is compared between the paracetamol and para-dexmedetomidine groups, and a t-test is used. When a categorical variable is compared with a categorical variable, the variables are represented in both tables and bar diagrams. For the test of significance, the Chi-square test is used. Fisher's exact test is used when more than 20% of the cell values have expected cell values <5. P < 0.05 were considered statistically significant. Data were entered in an MS Excel sheet and analyzed using IBM-SPSS software version 26 (Manufacturer: Bangalore, Karnataka, India).
| Results|| |
Among the patients screened for eligibility, those who met eligibility criteria were enrolled into two groups, excluding the dropouts, as shown in [Figure 1]. The demographic data of both groups were comparable. Results are derived with parameters such as VAS, rescue analgesia requirement, hemodynamic changes (MAP and heart rate), and Ramsay sedation score among the groups.
The mean VAS score at 6 h among Group P was 2.63 (± 1.43) which is higher by 0 and statistically significant compared to the mean VAS score at 6 h among Group DP which was 1.73 (± 1.14). The mean VAS score at 8 h among Group P was 1.47 (± 1.11) which is higher by 0.89 and statistically significant compared to the mean VAS score at 8 h among Group DP which was 1 (± 0). The mean VAS score at 4, 8, 10, and 12 h was higher in Group P but was not statistically significant [Table 1].
Considering the rescue analgesia of the subjects with drug group distribution, 59.37% of the Group P had rescue analgesia compared to Group DP of whom 23.33% had rescue analgesia and the difference was statistically significant (P < 0.05). Rescue analgesia requirements significantly showed that Group DP provided better analgesia [Table 2].
The mean heart rate at 2 h among Group P was 63.28 (± 5.81) which is lower by 20.82 and statistically significant compared to the mean heart rate at 2 h among Group DP which was 84.1 (± 8.38). The mean heart rate at 4 h among Group P was 63.76 (± 6.3) which is lower by 0 and statistically significant compared to the mean heart rate at 4 h among Group DP which was 81.67 (± 8.33). The mean heart rate at 6, 8, 10, and 12 h was not statistically significant [Figure 2].
The mean MAP at 2 h among Group P was 94.41 (± 6.3) which is higher by 8.48 and statistically significant compared to the mean MAP at 2 h among Group DP which was 85.93 (± 9.54). The mean MAP at 4, 6, 8, 10, and 12 h was not statistically significant to the mean MAP [Figure 3].
The mean sedation score at 2 h among Group P was 1 (± 0) which is lower by 2.8 and statistically significant compared to the mean sedation score at 2 h among Group DP which was 3.8 (± 0.81). The mean sedation score at 4 h among Group P was 1 (± 0) which is lower by 0 and statistically significant compared to the mean sedation score at 4 h among Group DP which was 2.57 (± 0.63). The mean sedation score at 6 h among Group P was 1 (± 0) which is lower by 1.57 and statistically significant compared to the mean sedation score at 6 h among Group DP which was 2.13 (± 0.51). The mean sedation score at 8 h among Group P was 1 (± 0) which is lower by 0 and statistically significant compared to the mean sedation score at 8 h among Group DP which was 1.57 (± 0.5). The mean sedation score at 10 h among Group P was 1 (± 0) which is lower by 1.13 and statistically significant compared to the mean sedation score at 10 h among Group DP which was 1.2 (± 0.41). The mean sedation score at 12 h among Group P was 1 (± 0) which is lower by 0.57 but not statistically significant compared to the mean sedation score at 12 h among Group DP which was 1.07 (± 0.25) [Table 3].
| Discussion|| |
The key objective of this research is the comparison of the efficacy of drugs in postoperative pain score, time for the first analgesic requirement, hemodynamic changes, and sedation.
Nath et al. did a prospective randomized study concluded that the dexmedetomidine blunts hemodynamic response of anesthetic and surgical stress when compared with Midazolam. In our study, the mean of MAP among Group DP was significantly lower compared to Group P at 2 h, later it was not significantly different score.
Imani et al. compared the postcesarean analgesic and observed the pain score was significantly lower with good maternal satisfaction in the dexmedetomidine and ketorolac group, compared with the dexmedetomidine and paracetamol group. Hemodynamic changes, amount of opioid use, complications, and sedation scale were similar. Similarly in our study also, the sedation score is better in Group DP, when calculated mean values at varying intervals. Furthermore, we noted that Group DP has better control over mean arterial blood pressure.
Subramaniam et al. observed that the administration of scheduled iv acetaminophen postoperatively for 48 h, combined with drugs such as iv propofol or dexmedetomidine will act as a sedative and can significantly reduce in-hospital delirium compared to that of a placebo (10% vs. 28%, respectively). In our study, the mean sedation score among Group DP was significantly higher compared to the mean sedation score among Group P throughout the postoperative period till 10 h.
Sharma et al., observed that the requirement of the postoperative analgesia was significantly decreased, with a decreased VAS score, improved patient-satisfaction score, and Ramsay-Sedation Score values among the group that received paracetamol. They concluded the addition of the dexmedetomidine as a part of multimodal analgesia provides a better analgesic action, good sedation, well maintained hemodynamic profile, and the severe adverse effects were significant. Similarly in our study, we proved that the dexmed group provides rescue analgesia over hours. Subsequent need for opioids is avoided.
Hadipourzadeh et al. evaluated the effect of adding paracetamol to dexmedetomidine in the management of pain following adult cardiac surgeries. DP group patients had lower levels of mean MAP and heart rate, required a lower dose of opioids, better analgesia, extubated earlier with lesser pain. In our study, 59.37% of Group P had rescue analgesia which is significantly higher compared to Group DP of whom 23.33%.
Our study design compares dexmedetomidine and dexmedetomidine-paracetamol, (instead of placebo) and hence the real effectiveness of the dexmedetomidine can be explored accurately.
Our study groups were not significantly different between the age, anthropometry (weight, height and BMI), procedure. The Heart rate was significantly higher and blood pressures (systolic, diastolic and MAP) was significantly lower at baseline, 2 h and 4 h. Later it was not significantly different.
Ramsay's sedation scale is an objective scale in our study and hence the possibility of subjective bias is nil. Our evaluation in this sedation score was higher in the DP group, implies postoperative comfort in patients.
Based on the outcome in our study, DP group has the control of mean arterial blood pressure for long hours, higher postoperative sedation scores and prolonged analgesia. Also DP group has good sedation score with slight hemodynamic change, reduces the stay in hospital, which is another important criteria.
| Conclusion|| |
The addition of dexmedetomidine, to the iv paracetamol, for patients undergoing gynecological procedures, effectively rendered satisfactory postoperative analgesia for a longer period delaying the time for the first analgesic requirement, along with a good sedation score with very minimal hemodynamic change. The combination of iv paracetamol and dexmedetomidine provides effective analgesia in comparison with opioids and can be rendered as an effective alternative for routine opioid analgesics.
The sample size was smaller to study the complications and other outcomes between the two groups. VAS pain score is a subjective scale, hence satisfaction and comfort of the patient will influence the results.
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Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3]
[Table 1], [Table 2], [Table 3]