Injection Site Pain Botulinum Toxin Reconstituted in NS With and Without Sodium Bicarbonate

Study Overview
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Brief Summary
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This study was designed to investigate the effects of botulinum toxin type A injections diluted with the mixture of sodium bicarbonate (SB) and normal saline (NS) on pain reduction, onset of action and duration of action. This is a prospective, randomized, double-blind clinical study, which included 30 female patients (age>25). The patients were randomized to receive botulinum toxin (BT) injections diluted with NS and SB on one side of the face and saline control injections on the other side. Pain severity was assessed using visual analogue scale. The onset and duration of action were recorded according to the patients' subjective opinions after 1 week and 3 months, respectively. The study was approved with an IRB (Institutional Review Board) number of RC19/371.

Official Title
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Injection Site Pain, Onset and Duration of Action of Botulinum Toxin Reconstituted in Normal Saline With and Without Sodium Bicarbonate; A Prospective, Single Center, Randomized, Double-Blind Interventional Study

Conditions
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Wrinkle

Intervention / Treatment
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* Drug: Sodium Bicarbonate
* Drug: Normal Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any female patient who is in good health and has moderate dynamic forehead and glabellar wrinkles. Exclusion Criteria: • Patients <25 years old Presence of neuromuscular disease or intake of drugs affecting muscle tone. Any active infection in the treatment area. Patients receiving anticoagulation or had a diagnosis of bleeding disorders. Any patient who had undergone the following treatments to the forehead area in the past 6 months: botulinum toxin injections, ablative laser procedures, radiofrequency device treatments, ultrasound device treatments, or medium to deep chemical peels. Any patient who had temporary soft-tissue augmentation material to the forehead area in the past 12 months, semi permanent soft-tissue augmentation material in the past 2 years, or permanent soft-tissue augmentation material at any point in the past. Any patient with prior facial cosmetic surgical procedures such as eyebrow-lifts, blepharoplasties, and rhytidectomies.

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sodium Bicarbonate<br> | Drug: Sodium Bicarbonate<br>* Botulinum Toxin diluted in Sodium Bicarbonate<br>|
| Placebo Comparator: Normal Saline<br> | Drug: Normal Saline<br>* 0.9 NaCl<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Injection site pain | Pain severity was assessed using Visual Analogue Scale (VAS).The VAS score ranged from 0 to 10, with 0 representing no pain and 10 the greatest imaginable pain. Higher scores indicated worse outcome. | Immediately after the injections |