Maryam Maghbool1, Tomaj Khosravi2, Salman Vojdani3, Mahsa Rostami Chaijan4, Fariba Esmaeili5, Amir Amani6, Fatemeh Rezayat7, Ramin Nasimi Doost Azgomi8, Shadan S Mehraban9, Mohammad Hashem Hashempur10. 1. Department of Pathology, Fasa University of Medical Sciences, Fasa, Iran. 2. Student Research Committee, Fasa University of Medical Sciences, Fasa, Iran. 3. Department of Anesthesiology, Fasa University of Medical Sciences, Fasa, Iran. 4. Department of Persian Medicine, Fasa University of Medical Sciences, Fasa, Iran. 5. Department of Medical Nanotechnology, School of Advanced Technologies in Medicine, Tehran University of Medical Sciences, Tehran, Iran. 6. Natural Products and Medicinal Plants Research Center, North Khorasan University of Medical Sciences, Bojnurd, Iran. 7. Department of Persian Medicine, School of Persian Medicine, Shahid Sadoughi University of Medical Sciences, Ardakan, Yazd, Iran. 8. Traditional Medicine, Hydrotherapy Research Center, Ardabil University of Medical Sciences, Ardabil, Iran. 9. Department of Obstetrics and Gynecology, Richmond University Medical Center, Staten Island, NY, USA. 10. Department of Persian Medicine, Fasa University of Medical Sciences, Fasa, Iran; Noncommunicable Diseases Research Center, Fasa University of Medical Sciences, Fasa, Iran. Electronic address: hashempur@gmail.com.
Abstract
OBJECTIVES: Local anesthetic and antinociceptive activity of eugenol, as the main ingredient of clove, was determined in previous researches. This study aimed to assess the efficacy of its topical nanoemulsion gel vs. placebo in controlling pain caused by arteriovenous fistula (AVF) needling in patients undergoing hemodialysis (HD). DESIGN: In this double-blinded cross-over trial, the patients were randomly allocated to eugenol gel 4% (n = 34) and placebo gel (n = 34) groups. For each patient, a tip of finger unit of gel was applied 2 cm around the insertion site of hemodialysis needles. After 10 min, AVF needling was done. AVF needling-related pain was assessed using visual analogue scale (VAS) immediately after the puncture. All patients were tested at three different states: (1) before using any intervention; (2) after using either the eugenol or placebo gel; and (3) after crossing over the groups. RESULTS: There was a significant difference between the mean of patients' pain severity score in the three states (p = 0.001). It was reported as low as 3.29 ± 0.67 in patients who received eugenol nanoemulsion. Also, the highest pain severity score (5.03 ± 0.57) was reported at the no-intervention state. CONCLUSIONS: It seems that topical application of eugenol nanoemulsion may significantly decrease AVF cannulation related pain intensity score in patients undergoing HD. However, further studies with larger sample size and longer intervention period should be done for better judgment on its efficiency and safety.
RCT Entities:
OBJECTIVES: Local anesthetic and antinociceptive activity of eugenol, as the main ingredient of clove, was determined in previous researches. This study aimed to assess the efficacy of its topical nanoemulsion gel vs. placebo in controlling pain caused by arteriovenous fistula (AVF) needling in patients undergoing hemodialysis (HD). DESIGN: In this double-blinded cross-over trial, the patients were randomly allocated to eugenol gel 4% (n = 34) and placebo gel (n = 34) groups. For each patient, a tip of finger unit of gel was applied 2 cm around the insertion site of hemodialysis needles. After 10 min, AVF needling was done. AVF needling-related pain was assessed using visual analogue scale (VAS) immediately after the puncture. All patients were tested at three different states: (1) before using any intervention; (2) after using either the eugenol or placebo gel; and (3) after crossing over the groups. RESULTS: There was a significant difference between the mean of patients' pain severity score in the three states (p = 0.001). It was reported as low as 3.29 ± 0.67 in patients who received eugenol nanoemulsion. Also, the highest pain severity score (5.03 ± 0.57) was reported at the no-intervention state. CONCLUSIONS: It seems that topical application of eugenol nanoemulsion may significantly decrease AVF cannulation related pain intensity score in patients undergoing HD. However, further studies with larger sample size and longer intervention period should be done for better judgment on its efficiency and safety.