Clinical Trials
Our pharmacy is to be involved in a double-blind clinical trial that includes an intravenous (IV) medication that is colored vs IV placebo. What can we do to avoid this color differentiation and to keep the trial double-blind?

The first step is to determine the intensity of the coloration of the intravenous medication in solution. Prepare the product as indicated by the protocol. In addition, prepare a product that contains the diluent only. Attach tubing to both products and prime. Examine both products under normal lighting. Then, examine both products under normal lighting with a white background behind them. Is the color difference obvious? Make sure your evaluation includes solution in the tubing of both products.

If the color difference is not obvious, then nothing further needs to be done to blind the products. If there is an obvious color difference, cover the bottle or bag with an opaque material, such as an amber IV cover or foil. Once again compare the product containing the active ingredient against one that contains only diluent solution.

If the color difference is obvious in the tubing, consider using tubing with coloration. There are several IV tubing products that have an amber or blue tint. Another strategy is to cover the tubing and drip chamber with foil or opaque amber plastic.