Abstract
Purpose
The aim of this study was to assess the effect of topical sucralfate on postoperative pain scores and other secondary outcomes including the frequency and duration of analgesic use and postoperative bleeding episodes after CO 2 laser treatment of oral leukoplakia.
Patients and Methods
In this prospective trial, a total of 80 patients were randomized into the sucralfate group (n = 40) or the control group (n = 40). Postoperative pain scores, the frequency and duration of analgesic requirements, and postoperative wound bleeding episodes were compared between the 2 groups from the operative day to postoperative day 6.
Results
Patients in the sucralfate group experienced significantly less postoperative pain on postoperative days 1 and 2. Although there was no significant difference in frequency and duration of analgesic use between the 2 groups, a trend toward lower frequency and fewer days of analgesic use in the sucralfate group was observed.
Conclusions
This study demonstrated the efficacy of topical sucralfate application in diminishing postoperative pain after CO 2 laser therapy for oral leukoplakia. Topical sucralfate can be considered a feasible adjuvant medication for the control of pain after CO 2 laser treatment of oral leukoplakia.
1
Introduction
Leukoplakia is a clinical term that refers to a white lesion of the oral mucosa that can potentially turn into oral squamous cell carcinoma. It is a common precancerous lesion in the oral cavity. There are many treatment modalities available for oral leukoplakia. Noninvasive methods include administration of 13- cis -retinoic acid and topical application of bleomycin . Surgical techniques include electrocoagulation, cryotherapy, and laser therapy.
Ben-Bassat et al pioneered the use of laser therapy for oral leukoplakia, and since then, many studies have found it to be an effective and safe treatment. Argon, potassium-titanyl phosphate, neodymium: yttrium-aluminum garnet, and carbon dioxide (CO 2 ) lasers have been used in the treatment of oral leukoplakia . However, the major issue during the postoperative period after laser surgery is the control of pain, and pain killers are usually the mainstay of treatment. Sucralfate is a disaccharide used in the management of peptic ulcers. It binds to the protein matrix of the ulcer, forming a protective barrier against gastric acid, bile salts, and pepsin. It may have a cytoprotective effect, speeding mucosal recovery .
We hypothesized that topical sucralfate could be used to decrease the severity of oral pain after laser surgery. This study was a prospective, randomized, controlled trial designed to examine the effect of topical sucralfate on postoperative pain score and other secondary outcomes including the frequency and duration of analgesic use and postoperative wound bleeding episodes after CO 2 laser treatment of oral leukoplakia.
2
Methods
2.1
Study design
We conducted a prospective, randomized, controlled trial to determine the effect of topical sucralfate for postoperative pain control after CO 2 laser treatment of oral leukoplakia for a period of 7 days. Adult patients who had undergone CO 2 laser therapy for conditions diagnosed as oral leukoplakia were eligible for the study. This study was approved by the Chang Gung Memorial Hospital Institutional Review Board. Patients were excluded if there was evidence of clinically significant disease that contraindicated their participation in the study. Failure to understand the end points of the study or an inability to complete the forms for data recording was also a criterion for exclusion from the study.
A total of 80 patients (average age, 50.1 years; range, 18–78 years) were recruited prospectively from February 2010 to August 2010 in the department of otolaryngology of a tertiary referral center in the southern part of Taiwan. The main outcome was the evaluation of pain scores during the first 7 days after surgery. Secondary outcomes were the evaluation of the frequency and duration of analgesic use and postoperative wound bleeding episodes.
2.2
Procedures
Preoperatively, patients were prospectively randomized into either the sucralfate group or the control group. For surgery, patients were placed in a supine position. The mouth was opened by a retractor, and local anesthesia (1% lidocaine) was used to infiltrate the lesion area. A CO 2 laser (SHARPLAN 1080S) with continuous mode 10-W power was used to resect the mucosal lesions. At the completion of surgery, the estimated wound size was measured as the long axis (in centimeters) times the short axis (in centimeters).
After surgery, the patient was instructed to rinse his or her mouth with 1 g of sucralfate diluted in 10 mL of water (sucralfate group) or 10 mL of water without sucralfate (control group) for 2 minutes and then swallow it, 4 times a day for a period of 7 days. All patients were prescribed with acetaminophen 500 mg tablets orally for pain control if necessary, and the dose was limited to within 2000 mg/day.
2.3
Study protocol
Eligible patients were informed about the study and asked to fill out a questionnaire, which assessed the level of the postoperative pain, the frequency, and duration of analgesic use and the postoperative wound bleeding episodes ( Fig. 1 ). Variables for the study were recorded every day in the questionnaire provided for the patients. Postoperative pain was evaluated with a visual analog scale, which was recorded by the patients from the operative day to postoperative day 6. The level of pain was ranked from 0 (no pain) to 10 (very severe pain). For pain relief, acetaminophen 500 mg tablets were prescribed to be used every 6 hours when necessary. The frequency of acetaminophen use, from 0 to 4 times a day, was also to be recorded in the questionnaire. Postoperative wound bleeding episodes were evaluated as the presence of active bleeding, presence of blood in saliva, or absence of bleeding. The completed data from the questionnaires were collected for analysis 1 week after the surgery.
2.4
Statistical analysis
Data with regard to wound sizes, postoperative pain scores, and analgesic use are presented as means and standard deviation (SD). Pain scores at each time interval were compared between groups using the Mann-Whitney U test. The estimated wound sizes and analgesic requirements were compared between groups using the 2-sample t test.
2
Methods
2.1
Study design
We conducted a prospective, randomized, controlled trial to determine the effect of topical sucralfate for postoperative pain control after CO 2 laser treatment of oral leukoplakia for a period of 7 days. Adult patients who had undergone CO 2 laser therapy for conditions diagnosed as oral leukoplakia were eligible for the study. This study was approved by the Chang Gung Memorial Hospital Institutional Review Board. Patients were excluded if there was evidence of clinically significant disease that contraindicated their participation in the study. Failure to understand the end points of the study or an inability to complete the forms for data recording was also a criterion for exclusion from the study.
A total of 80 patients (average age, 50.1 years; range, 18–78 years) were recruited prospectively from February 2010 to August 2010 in the department of otolaryngology of a tertiary referral center in the southern part of Taiwan. The main outcome was the evaluation of pain scores during the first 7 days after surgery. Secondary outcomes were the evaluation of the frequency and duration of analgesic use and postoperative wound bleeding episodes.
2.2
Procedures
Preoperatively, patients were prospectively randomized into either the sucralfate group or the control group. For surgery, patients were placed in a supine position. The mouth was opened by a retractor, and local anesthesia (1% lidocaine) was used to infiltrate the lesion area. A CO 2 laser (SHARPLAN 1080S) with continuous mode 10-W power was used to resect the mucosal lesions. At the completion of surgery, the estimated wound size was measured as the long axis (in centimeters) times the short axis (in centimeters).
After surgery, the patient was instructed to rinse his or her mouth with 1 g of sucralfate diluted in 10 mL of water (sucralfate group) or 10 mL of water without sucralfate (control group) for 2 minutes and then swallow it, 4 times a day for a period of 7 days. All patients were prescribed with acetaminophen 500 mg tablets orally for pain control if necessary, and the dose was limited to within 2000 mg/day.
2.3
Study protocol
Eligible patients were informed about the study and asked to fill out a questionnaire, which assessed the level of the postoperative pain, the frequency, and duration of analgesic use and the postoperative wound bleeding episodes ( Fig. 1 ). Variables for the study were recorded every day in the questionnaire provided for the patients. Postoperative pain was evaluated with a visual analog scale, which was recorded by the patients from the operative day to postoperative day 6. The level of pain was ranked from 0 (no pain) to 10 (very severe pain). For pain relief, acetaminophen 500 mg tablets were prescribed to be used every 6 hours when necessary. The frequency of acetaminophen use, from 0 to 4 times a day, was also to be recorded in the questionnaire. Postoperative wound bleeding episodes were evaluated as the presence of active bleeding, presence of blood in saliva, or absence of bleeding. The completed data from the questionnaires were collected for analysis 1 week after the surgery.
