Impact of osmolality on burning sensations during and immediately after intramuscular injection of 0.5 ml of vaccine suspensions in healthy adults.

Abstract	A randomised placebo controlled double-blind cross-over trial was performed on twenty healthy adults to assess the effect of osmolality (300,600,850 and 1100 mOsm) on local tolerance of an intramuscular injection (0.5 ml) of five suspensions containing the same components as the excipients of a combined Diphtheria-Tetanus-acellular Pertussis-inactivated Poliomyelitis-Haemophilus influenzae type b paediatric vaccine (DtacP-IPV-Hib, PENTAVAC). The results did not show any dose-effect relationship between burning or pain sensations and the different osmolalities tested. Although mild and not clinically relevant, these sensations seemed to occur more frequently following injection of an isotonic saline solution (P<0.05). Thus, the osmolality of vaccine like suspensions does not appear to be a potential cause of local pain or burning sensation after their administration.
Authors	P Nony, P Girard, S Chabaud, L Hessel, C Thébault, J P Boissel
Journal	Vaccine (Vaccine) Vol. 19 Issue 27 Pg. 3645-51 (Jun 14 2001) ISSN: 0264-410X [Print] Netherlands
PMID	11395198 (Publication Type: Clinical Trial, Clinical Trial, Phase I, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References	Diphtheria-Tetanus-Pertussis Vaccine Excipients Haemophilus Vaccines Pentavac Poliovirus Vaccine, Inactivated Serum Albumin Vaccines, Combined Sodium Chloride Aluminum Hydroxide
Topics	Adolescent Adult Aluminum Hydroxide (administration & dosage, adverse effects) Cross-Over Studies Diphtheria-Tetanus-Pertussis Vaccine Double-Blind Method Excipients (administration & dosage, adverse effects) Female Haemophilus Vaccines Humans Injections, Intramuscular (adverse effects) Male Osmolar Concentration Pain (etiology) Pain Measurement Poliovirus Vaccine, Inactivated Serum Albumin (administration & dosage, adverse effects) Sodium Chloride (administration & dosage, adverse effects) Vaccines, Combined (administration & dosage, adverse effects)

Join CureHunter, for free Research Interface BASIC access!

Take advantage of free CureHunter research engine access to explore the best drug and treatment options for any disease. Find out why thousands of doctors, pharma researchers and patient activists around the world use CureHunter every day.

Realize the full power of the drug-disease research graph!