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A randomized controlled trial comparing esophageal manometry and ambulatory pH monitoring test tolerance in the presence versus in the absence of topical lidocaine.
Conventionally, topical nasopharyngeal anesthesia is applied to improve the tolerance of esophageal manometry and ambulatory pH monitoring. However, there is currently no data to support this practice. This randomized controlled trial of lidocaine versus placebo applied before these tests will evaluate the benefit of topical lidocaine anesthesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine | Experimental | Patients randomized to the lidocaine intervention will receive 2 sprays of lidocaine hydrochloride 10% in each nostril 3-5 minutes before their test. |
|
| Placebo (Saline) | Placebo Comparator | Patients randomized to placebo will receive 2 sprays of physiological saline in each nostril 3-5 minutes before their test. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saline spray | Drug | Physiologic saline spray |
| |
| Lidocaine Hydrochloride |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of pain during catheter insertion | As reported by patients on a standardized questionnaire | Assessed once immediately after exam on patient questionnaire |
| Measure | Description | Time Frame |
|---|---|---|
| Global patient satisfaction | As reported by patients on a standardized questionnaire (on scale of 1 to 5, 5 being highest satisfaction score) | Assessed once immediately after exam on patient questionnaire |
| Presence of other complications during catheter insertion |
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Inclusion Criteria:
Adult patients undergoing esophageal manometry or ambulatory pH monitoring at our center who are able to read and consent to participate in the study.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre hospitalier de l'Université de Montréal | Montreal | Quebec | Canada |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Drug |
Lidocaine hydrochloride 10% spray |
|
As reported by patients on a standardized questionnaire |
| Assessed once immediately after exam on patient questionnaire |
| Presence of complications during test recording | As reported by patients on a standardized questionnaire | Assessed once immediately after exam on patient questionnaire |
| Aniline Compounds |
| D000588 | Amines |