Comparative Analgesic Efficacy of Intramuscular Dexamethasone, Ketorolac, Tramadol, and Butorphanol with Regard to Postoperative Pain After Mandibular Third Molar Surgery

ABSTRACT

Surgical removal of the third molar often resulted in postoperative pain which affected the quality of life of the patients. Pharmacological management of pain includes NSAIDS or steroids. The present study compared four drugs, viz. Group 1 (4 mg dexamethasone injection); Group 2 (30 mg ketorolac); Group 3 (50 mg tramadol injection); and Group 4 (1 mg butorphanol injection) in the management of postoperative pain after third molar surgery. We observed that in comparison with the first and third postoperative pain between groups, it revealed the lowest mean pain score in the butorphanol group, followed by dexamethasone and tramadol group and the highest mean score in the ketorol group (P value <0.0001). We conclude that butorphanol with low dosage can be effectively used for reducing postoperative discomfort after surgery.

BACKGROUND

Surgical extraction of the impacted third molar is one of the most performed surgical procedures in the field of oral and maxillofacial surgery. The procedure is typically correlated with postoperative pain, facial swelling, and trismus. while complications such as infection, dry socket, inferior alveolar nerve, or lingual nerve injuries are less common to occur.[1]

NSAIDs, opioids, corticosteroids, and a combination of analgesics are commonly used pre- or postoperatively for pain relief. These medications are used to suppress inflammatory mediators and reduce pain, transudation of fluids, and edema.[2]

With this clinical background, this study aimed to clarify the possible role of four postoperative analgesics, either dexamethasone (4 mg), butorphanol tartrate (1 mg), tramadol hydrochloride (50 mg), and ketorolac (30 mg) administered 10 min after surgery, in clinical recovery after third molar surgery.

MATERIAL AND METHODS

The study was approved by the Institutional Research Committee and conducted as a single-blind randomized controlled clinical trial was conducted on 80 individuals who were healthy with an orthodontic indication of bilateral upper and lower third molar removal and aged 15 to 30 years old with a Pederson’s difficulty score between five and eight. Heavy smokers (≥ 20 cigarettes per day); uncontrolled systemic conditions; acute infection of the surgical site; pregnant women; psychological problems; history of allergy to studied drugs were excluded.

Participants who were eligible to participate were randomly allocated to four groups of patients: Group 1 (4 mg dexamethasone injection); Group 2 (30 mg ketorolac); Group 3 (50 mg tramadol injection); and Group 4 (1 mg butorphanol injection). The surgical extraction was carried out using a conventional technique with rotatory instruments. All the patients were advised for amoxicillin 500 mg orally every 8 h for 7 days as a prophylactic antimicrobial agent, and ibuprofen 600 mg was prescribed orally every 8 h as analgesia therapy to all patients in the study. Routine post-surgical instructions were advised to the patients. During the postoperative period, patients received the aforementioned dosage of intramuscular drug in the gluteus maximus muscle over the lateral aspect of the buttocks.

Study outcomes assessed were the visual analog (VAS) for postoperative pain of the patient on days 1, 3, and 7.

Statistical analysis

Data analyses were performed using the statistical software SPSS version 22.0. Demographic characteristics of the patients were compared across the four groups using the Chi-squared test for categorical variables and analysis of variance (ANOVA) or Kruskal–Wallis for continuous variables as appropriate.

RESULTS

Baseline demographic characteristics were highlighted in Table 1. Among the four groups, the mean pain score was the highest on the first day and gradually decreased over the following days (p value < 0.0001). Statistically significant reductions in pain levels from day 1 to day 3 and from day 3 to day 7 in all four groups (P < 0.0001) were found in all groups. Comparison of the first and third postoperative pain between groups revealed a lowest mean pain score in the butorphanol group, followed by dexamethasone and tramadol group and a highest mean score in the ketorol group (p value < 0.0001) [Table 2].

Table 1.

Baseline characteristics and surgical working times of the study patients

	Group 1 n=20	Group 2 n=20	Group 3 n=20	Group 4 n=20	P
Age (Mean±SD)	19.8±2.41	19.958±2.35	19.88±2.80	20.18±3.00	0.966
Gender n (%)					0.801
Male	9 (45)	10 (50)	11 (55)	8 (40)
Female	11 (55)	10 (50)	9 (45)	12 (60)
Pederson difficulty score (Mean±SD)	6.45±1.09	6.35±0.98	6.4±1.09	6.55±1.23	0.951

SD—standard deviation, n—frequency, %—percentage, P<0.05 is considered significant

Table 2.

Pain levels between groups at first, third, and seventh postoperative days between groups

	Group 1 n=20	Group 2 n=20	Group 3 n=20	Group 4 n=20	P
Pain levels
Post-op day 1	4.15±1.2	5.4±1.0	4.25±1.0	3.3±1.0	<0.0001
Post-op day 3	2.8±1.5	3.75±1.0	2.85±1.1	2.2±0.61	<0.0001
Post-op day 7	1.1±2.07	2±1.51	1.3±1.55	0.7±0.57	0.064
P	<0.0001	<0.0001	<0.0001	<0.0001

Data are presented as mean and standard deviation, n–frequency, P<0.05 is considered significant

DISCUSSION

Our study is the first to compare the analgesic efficacy of four drugs post-third molar surgery. Our findings could be well-attributed to the mechanism of the action of respective drugs. Butorphanol tartrate (BT) is an opioid analgesic that acts as an agonist–antagonist at μ and δ receptors and as a partial agonist at κ receptors. It has a potency approximately 4 to 8 times that of morphine with a long duration (4–5 h) and rapid onset (5–15 min) of action accompanied by an excellent safety profile. Furthermore, it has a low dependence liability and abuse potential.[3] In comparison, dexamethasone is a long-acting corticosteroid, which has a potent anti-inflammatory effect, mainly by promoting the synthesis of regulatory proteins of the inflammatory process, such as lipocortin and vasocortin.[4]

Ketorolac tromethamine is a non-selective COX inhibitor and has important analgesic, anti-inflammatory, and antipyretic properties[5], while tramadol [(1R,2R)-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexane-1-ol)] is a central action opiate that is clinically effective for the control of moderate to intense pain. It is an agonist of the μ-opioid receptor that reduces the transmission of pain impulses by inhibiting the reuptake of serotonin and norepinephrine.[6]

CONCLUSION

Under the limitations of this study, it can be concluded that postoperative intramuscular injection of butorphanol, ketorolac, dexamethasone, and tramadol is similarly effective in pain control after impacted third molar surgeries. However, butorphanol with low dosage can be effectively used for reducing postoperative discomfort after surgery.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.