drugset
drugset / Trial / NCT04579419

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

NCT04579419 ↗

Phase 3 Completed 30 enrolled King Abdulaziz Medical City
RandomizedParallel-groupTriple-blindTreatment

Summary

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.

Timeline

Start
2019-11-09
Primary completion
2020-08-09
Completion
2020-08-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Botulinum toxin Protein / enzyme biologic — —
Subject sodium bicarbonate Diagnostic / imaging agent — —

Indications

No indication recorded.