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Study aim
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To compare Valsalva maneuver, lidocaine, and Valsalva maneuvers along with administration of lidocaine to reduce the pain associated with administration of etomidate in Alzahra hospital in 2019
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Design
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Open label randomized clinical trial, with three parallel groups, randomized with block randomization, phase 3, on 90 patients overall.
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Settings and conduct
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The study is a clinical trial, in which cases are devided into 3 groups by block randomization: 1.Valsalva maneuver,2.lidocaine, and 3.Valsalva maneuver along with prescription of lidocaine. It will be carried out in October 2020, in Alzahra hospital, Isfahan, Iran. After informed consent, Candidates for sedation with Etomidate are divided in 3 groups and their demographic information and VAS scores are recorded. Only data analyst is blinded in this study.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
1. physical class I or II
2. Age between 18 to 65
3. Etomidate administration as sedative.
Exclusion criteria:
1. History of mental, cardiac and respiratory disease
2. Chronic pain disorders
3. Long history of analgesic use
4. History of allergic reactions to etomidate or lidocaine
5. History of drug abuse
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Intervention groups
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Group 1- Performing Valsalva maneuver by the patient ; 2- Lidocaine injection; and 3- Lidocaine injection while the patient is performing Valsalva maneuver.
Lidocaine dose is 1 mg/Kg of body patient's weight slow bolus intravenous (over 2-3 min).
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Main outcome variables
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Visual Analog Scale (VAS) for pain
Objective physician-assessed pain score; with:
0= no pain;
1= mild pain, pain that only is reported by the patient, and no signs of pain are observed by the physician;
2= Moderate pain, one pain sign is observed in addition to patient's report
3= Severe pain with loud noise or moaning.