Comparison of the Effects of Diltiazem Gel with Lidocaine Gel on Reducing Pain and Discomfort in Patients Undergoing Rectosigmoidoscopy: A Randomized Double-blinded Clinical Trial

Page: [204 - 208] Pages: 5

  • * (Excluding Mailing and Handling)

Abstract

Background: Flexible rectosigmoidoscopy is an easy and accessible exam to diagnose distal colon diseases, although many patients refuse to undergo it due to pain and discomfort during the procedure. Studies show that the application of local lidocaine, as an analgesic has no effect on pain relief in patients undergoing rectosigmoidoscopy. The current study aims at comparing the effects of diltiazem gel, an antispasmoic drug with local pain-reducing effects, with lidocaine gel in patients undergoing flexible rectosigmoidoscopy.

Materials and Methods: The current double-blinded, randomized, clinical trial was performed to compare the effect of two topical drugs, lidocaine and diltiazem, on pain relief in patients undergoing rectosigmoidoscopy. A total of 80 patients who were potential candidates for rectosigmoidoscopy were enrolled in the study after obtaining the informed consent and then randomly assigned to one of the lidocaine gel (2 mL) or diltiazem gel (2 mL) group, 10 minutes prior to rectosigmoidoscopy. The level of pain in the patients during the procedure was measured using the visual analogue scale (VAS) and the results were recorded. The data were analyzed using paired samples ttest and independent t-test as well as analysis of covariance (ANOVA) with SPSS version 18. P-value <0.05 was considered the level of significance.

Results: Of 80 patients, 35 (43.75%) were male and 45 (56.25%) female. The mean age and body mass index (BMI) of the patients were 51.45 ± 15.21 years and 25.95 ± 7.47 kg/m2, respectively, and there was no significant difference between the groups. The most frequent indications for rectosigmoidoscopy were abdominal pain (46.3%) and rectorrhagia (31.3%). The mean VAS score for pain reported by the patients in the lidocaine and diltiazem groups was 3.97 ± 2.89 and 2.60 ± 2.36, respectively. The VAS score for pain in the diltiazem group was significantly lower than lidocaine group (P = 0.023).

Conclusion: The application of local diltiazem gel around the anus, in spite of no side effects, can effectively reduce the pain and discomfort in patients during rectosigmoidoscopy. Iranian Registry of Clinical Trials (Reg. No 31055).

Keywords: Rectosigmoidoscopy, diltiazem gel, analgesia, abdominal pain, lidocaine, rectorrhagia.

Graphical Abstract

[1]
Schoen RE, Machicado JD. Detection of advanced neoplasia with FIT versus flexible sigmoidoscopy versus colonoscopy: more is more. Dig Dis Sci 2015; 60(5): 1123-5.
[http://dx.doi.org/10.1007/s10620-015-3583-2] [PMID: 25701322]
[2]
Bretthauer M, Hoff G, Thiis-Evensen E, et al. Carbon dioxide insufflation reduces discomfort due to flexible sigmoidoscopy in colorectal cancer screening. Scand J Gastroenterol 2002; 37(9): 1103-7.
[http://dx.doi.org/10.1080/003655202320378329] [PMID: 12374237]
[3]
Harding TA, Gibson JA. The use of inhaled nitrous oxide for flexible sigmoidoscopy: a placebo-controlled trial. Endoscopy 2000; 32(6): 457-60.
[http://dx.doi.org/10.1055/s-2000-652] [PMID: 10863911]
[4]
Lin OS, Kozarek RA, Cha JM. Impact of sigmoidoscopy and colonoscopy on colorectal cancer incidence and mortality: an evidence-based review of published prospective and retrospective studies. Intest Res 2014; 12(4): 268-74.
[http://dx.doi.org/10.5217/ir.2014.12.4.268] [PMID: 25374491]
[5]
Chlan L, Evans D, Greenleaf M, Walker J. Effects of a single music therapy intervention on anxiety, discomfort, satisfaction, and compliance with screening guidelines in outpatients undergoing flexible sigmoidoscopy. Gastroenterol Nurs 2000; 23(4): 148-56.
[http://dx.doi.org/10.1097/00001610-200007000-00003] [PMID: 11310081]
[6]
Antunes AA, Calado AA, Lima MC, Falcão E. Efficacy of intrarectal lidocaine hydrochloride gel for pain control in patients undergoing transrectal prostate biopsy. Int Braz J Urol 2004; 30(5): 380-3.
[http://dx.doi.org/10.1590/S1677-55382004000500004] [PMID: 15610569]
[7]
Chang SS, Alberts G, Wells N, Smith JA Jr, Cookson MS. Intrarectal lidocaine during transrectal prostate biopsy: results of a prospective double-blind randomized trial. J Urol 2001; 166(6): 2178-80.
[http://dx.doi.org/10.1016/S0022-5347(05)65529-2] [PMID: 11696730]
[8]
Griffin N, Acheson AG, Jonas M, Scholefield JH. The role of topical diltiazem in the treatment of chronic anal fissures that have failed glyceryl trinitrate therapy. Colorectal Dis 2002; 4(6): 430-5.
[http://dx.doi.org/10.1046/j.1463-1318.2002.00376.x] [PMID: 12790914]
[9]
Akhondi-Meybodi M, Kargar S, Emadi S. A prospective randomized trial of diltiazem gel and glyceryl trinitrate ointment on treatment of chronic anal fissure. JSS Univ Med Sci 2014; 22(5): 1445-54.
[10]
Tsunoda A, Kashiwagura Y, Hirose K, Sasaki T, Kano N. Quality of life in patients with chronic anal fissure after topical treatment with diltiazem. World J Gastrointest Surg 2012; 4(11): 251-5.
[http://dx.doi.org/10.4240/wjgs.v4.i11.251] [PMID: 23494072]
[11]
Bukhari ST. Atiq-ur-Rehman S, Abdullah MS, Bukhari ST, Iqbal J. Anal fissure: comparison of effectiveness of 2% diltiazem ointment to 0.2% glyceryl trinitrate ointment in treatment. Prof Med J 2017; 24(9)
[12]
Sugimoto T, Tsunoda A, Kano N, Kashiwagura Y, Hirose K, Sasaki T. A randomized, prospective, double-blind, placebo-controlled trial of the effect of diltiazem gel on pain after hemorrhoidectomy. World J Surg 2013; 37(10): 2454-7.
[http://dx.doi.org/10.1007/s00268-013-2124-4] [PMID: 23775515]
[13]
Eshagh Hosseeyni SJ, Ahmadi A, Kachooie A. The efficacy of diltiazem on diminution of patients’ complaints after anal surgery. Qom Univ Med Sci J 2008; 1(2): 15-23.
[14]
Rafiei M, Dehkhoda S, Ghergherehchi M, Shahvaraninasab A. Comparison of post operative analgesia with preoperative topical lidocaine gel and lubricant gel in hemorrhoidectomy operation. Iranian J Surg 2008; 15(4): 28-33.
[15]
Cengiz C, Pampal HK, Ozdemir B, Boyacioglu S, Kuzu MA. No effect of perianal application of topical anaesthetic on patient comfort during nonsedated flexible sigmoidoscopy: a randomized, placebo-controlled clinical trial. Colorectal Dis 2012; 14(7): 872-5.
[http://dx.doi.org/10.1111/j.1463-1318.2011.02812.x] [PMID: 21899708]
[16]
Nam SH, Kim KH, Choi C, Nam SH, Song T, Lee KW. Lidocaine gel versus plain lubricating gel for pain reduction during transrectal sonography (LIPS): A randomized controlled trial. Eur J Obstet Gynecol Reprod Biol 2017; 212(212): 60-4.
[http://dx.doi.org/10.1016/j.ejogrb.2017.03.012] [PMID: 28342390]