van yuzuncu yil university, Bardakçı, Yüzüncü Yıl Ünv., 65080 Tuşba/Van
Van, 65000, Turkey (Türkiye)
NCT Number: NCT06885723
SUMMARY Intratympanic injections commonly cause pain in the patients. Intratympanic steroid injection (ITS) application can be performed by direct injection without anesthesia or with local anesthesia induced by lidocaine spray, lidocaine injection, topical phenol, pantocaine, EMLA cream (lidocaine+prilocaine) or vibration anesthesia device (VAD). The advantage of VAD application over other anesthetic agents was that it eliminated the need to use local anesthetics that may disrupt wound healing. In addition, inducing anesthesia with VAD can be considered as an alternative method in patients allergic to drugs.
Looking for future studies?
Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Van, 65000, Turkey (Türkiye)
ABSTRACT In this study, we aimed to compare the efficacy of four methods including topical lidocaine spray, local anesthetic cream, vibration anesthesia device (VAD), and saline drops (control group) in the reduction of pain after intratympanic steroid injections (ITS's) and to demonstrate the effectiveness of VAD use. The prospective study included 40 patients aged 18-70 years with idiopathic sudden sensorineural hearing loss. Prior to each ITS, all the four methods including local anesthetic cream (EMLA® cream, AstraZeneca PLC), lidocaine spray (Vemcain® Spray), VAD (Blaine®, Blaine Labs, Santa Fe, USA), and saline drops (control) were administered in each patient. After each ITS, pain assessment was performed using Visual Analogue Scale (VAS), Numerical Rating Scales (NRS), and Verbal Rating Scales (VRS).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
In conclusion, induction of anesthesia with VAD in patients treated with ITS provided pain palliation in a similar way to other local anesthetic techniques. Moreover, the advantage of VAD application over other anesthetic agents was that it eliminated the need to use local anesthetics that may disrupt wound healing. In addition, inducing anesthesia with VAD can be considered as an alternative method in patients allergic to drugs. Our study will shed light on different techniques such as the application of ventilation tube in anesthesia with VAD.
Prior to each ITS, all the four methods including local anesthetic cream (EMLA® cream, AstraZeneca PLC), lidocaine spray (Vemcain® Spray), VAD (Blaine®, Blaine Labs, Santa Fe, USA), and saline drops (control) were administered in each patient. The order of administration was determined for each patient using the randomization software (random.org/lists/). For the fifth ITS, however, the method of administration was selected by the patient.
Prior to each ITS, all the four methods including local anesthetic cream (EMLA® cream, AstraZeneca PLC), lidocaine spray (Vemcain® Spray), VAD (Blaine®, Blaine Labs, Santa Fe, USA), and saline drops (control) were administered in each patient. The order of administration was determined for each patient using the randomization software (random.org/lists/). For the fifth ITS, however, the method of administration was selected by the patient.
Prior to each ITS, all the four methods including local anesthetic cream (EMLA® cream, AstraZeneca PLC), lidocaine spray (Vemcain® Spray), VAD (Blaine®, Blaine Labs, Santa Fe, USA), and saline drops (control) were administered in each patient. The order of administration was determined for each patient using the randomization software (random.org/lists/). For the fifth ITS, however, the method of administration was selected by the patient.
Time frame: 56 weeks
Visual Analogue Scale (VAS). the visual analog scale (VAS) scaled between 0-10,were used.
Time frame: 56 weeks
Eleven-Point Numeric Rating Scale (NRS-11). the numerical rating scale (NRS) scaled between 0-10 were used.
Time frame: 56 weeks
Four-Category Verbal Rating Scale (VRS-4). the verbal rating scale (VRS) scaled between 0-4 were used.
Yuzuncu Yil University
Other
Evaluation of Different Anesthesia Methods to Reduce Pain From Intratympanic Injections: A Prospective, Randomized Clinical Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05086276
Ear Diseases, Hearing Disorders
Tucson, Arizona, United States
View Trial DetailsNCT04601909
Ear Diseases, Hearing Disorders
Sarasota, Florida, United States
View Trial DetailsNCT04629664
Ear Diseases, Hearing Disorders
Novi, Michigan, United States
View Trial DetailsNCT07505667
Ear Diseases, Hearing Disorders
Guangzhou, Guangdong, China
View Trial Details