Comparison of Effectiveness of Ear Syringing With or Without Pre-Ear Oil Application , Non-randomized Control Trial.

Cerumen Impaction of Both Ears Clinical Trial

Official title:

Comparison of Effectiveness of Ear Syringing With or Without Pre-Ear Oil Application , Non-randomized Control Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04094116
• Other study ID #: WON-20190902-11381
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: September 2019
• Source: Hospital Authority, Hong Kong
• Contact: Chang Wells (resident)
• Phone: 97506274
• Email: wellschang[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients in Wong Siu Ching Clinic and Tai Po Clinic who are found to have ear wax after physical examination will have ear syringing done, without pre-ear oil application. On the other hand, patients in Fanling Family Medicine Centre with ear wax will be given ear oil one week before performing ear syringing. We will compare the respective success rates of ear syringing from these 2 groups, the mean numbers of syringing attempts , as well as any complications such as ear canal abrasion, ear drum perforation, any pain or vertigo reported by patients. For those cases who fail ear syringing , olive oil will be prescribe and arrange 1 week follow up for ear syringing .

Description:

Patients in Wong Siu Ching Clinic and Tai Po Clinic who are found to have ear wax after physical examination will have ear syringing done, without pre-ear oil application. On the other hand, patients in Fanling Family Medicine Centre with ear wax will be given ear oil one week before performing ear syringing. We will compare the respective success rates of ear syringing from these 2 groups, the mean numbers of syringing attempts, subjective improvement in hearing , as well as any complications such as ear canal abrasion, ear drum perforation, any pain or vertigo reported by patients. For those cases who fail ear syringing , olive oil will be prescribe and arrange 1 week follow up for ear syringing .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Patients >18 years old, who complain about blocked ear found to have ear wax which impacts ear drum and able to sign consent.

Exclusion Criteria:

• Patients who are contraindicated to ear syringing will be excluded : otitis externa , otitis media , history of tympanic membrane perforation , history or ear surgery , unilateral deafness , in-co-operated patient (eg. Children ) , history of vertigo after ear syringing .

Related Conditions & MeSH terms

• Cerumen Impaction of Both Ears

Intervention

Procedure:
• ear wax syringing without pre ear oil treatment
Active Comparator: ear wax syringing with pre ear oil treatment Sham Comparator: ear wax syringing without pre ear oil treatment

Locations

Country	Name	City	State
Hong Kong	Fanling Family MEdicine Centre , 1/F , 2 , Pik Fung Road , Fan Ling	Hong Kong
Hong Kong	Tai Po Jockey Club Clinic , 37 Ting Kok Road , Tai Po , Hong Kong	Hong Kong
Hong Kong	Wong Siu Ching Family Medicine centre . 1 , Po Wu Lane , Tai Po	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Authority, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (1)

Eekhof JA, de Bock GH, Le Cessie S, Springer MP. A quasi-randomised controlled trial of water as a quick softening agent of persistent earwax in general practice. Br J Gen Pract. 2001 Aug;51(469):635-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mean number of syringing attempts (50 ml syringe)	For both groups the mean number of syringing attempts (and 95% confidence interval) is calculated and compared by testing the difference between the means, using a t test for independent samples. For patients with persistent earwax in both ears , the mean number of syringing attempts needed for both ears in one patient is used for the calculations . All ears in which the wax is still persistent after another 10 syringing attempts are given a value of 11 in the calculations . Data for this study is analyzed using SPSS version 26 .	1 day
Secondary	The presence of ear canal abrasion,	The presence of ear canal abrasion,	1 month

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