Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

The Effect of Needle Temperature on Pain Ratings Following Intramuscular Injection

This study has been completed.
Information provided by:
University of Wisconsin, Madison Identifier:
First received: September 13, 2005
Last updated: January 14, 2008
Last verified: January 2008

This study will determine whether decreasing pain associated with intramuscular injection by decreasing needle temperature could be an inexpensive, simple way to decrease injection fear and increase immunization rates.

Condition Intervention
Device: 22 gauge 1 1/2 inch needles on a 3 ml syringe

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double-Blind
Official Title: The Effect of Needle Temperature on Pain Ratings Following Intramuscular Injection

Resource links provided by NLM:

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Pain level

Secondary Outcome Measures:
  • Antibody Response

Estimated Enrollment: 80
Study Start Date: October 2005
Study Completion Date: January 2007
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: 22 gauge 1 1/2 inch needles on a 3 ml syringe
    cold needles or needles kept at room temperature
Detailed Description:

Influenza virus infection causes significant morbidity and mortality each season. More than 90 million doses of influenza vaccine are administered in most seasons. All of these vaccine doses, except about two million, are administered by intramuscular injection. Surprisingly little research has been done to evaluate appropriate intramuscular injection technique.

A small proportion of the population for which annual influenza immunization is indicated may self-defer because of the pain associated with the administration of the vaccine. Injection is a procedure that causes minor pain. Ice packs are often used for local anesthesia. Decreasing pain associated with intramuscular injection by decreasing needle temperature could be an inexpensive, simple way to decrease injection fear and increase immunization rates.

To test our hypothesis, we will use a double blind controlled study design. Study participants will receive two injections. One injection will contain 0.5ml of next season's influenza vaccine. The other injection will contain 0.5ml normal saline. Each study participant will be randomly assigned to order of injection and to frozen or room temperature needle. (Figure 1) We include two injections to increase the amount of information that we can obtain from the study. In addition to determining if frozen needles decrease discomfort associated with injection of influenza vaccine, we may be able to make our study more generalizable if frozen needles also decrease the pain associated with a normal saline intramuscular injection. Further rationale for the study design covers that we are unable to administer the same injection at two sites to the same person during the same visit varying only the temperature of the needle. To minimize variability, both injections will be administered by the same immunizer who will be blind to the study group assignment. We will maintain blinding of the immunizer by having the person preparing the injections hand the filled syringes to the immunizer uncapped since the immunizer would likely be able to feel the cold of the frozen needles during the needle uncapping. A 1 inch 23 gauge needle (safety injection device; Eclipse by BD, Franklin Lakes, NJ) will be used for all participants under 90kg. A 1 ½ inch needle will be used for all larger participants. We will ask each individual to rate the pain of each injection using a standard 10 point pain scale.1 Each participant will be asked which injection was less painful and if he/she can tell us if a frozen needle was used for either or both injection. Members from the research team will call or email subjects 2-4 days after the administration of the injection. During this phone call, subjects will be asked to rate their current pain at both injection sites. They will also be asked if they notice any redness around the injection site. This additional phone call will help to determine if needle temperature affects delayed injection site reactions (minor soreness and/or redness around the injection site lasting 1-3 days after the injection) in addition to immediate effects.

To determine if there is an effect on influenza vaccine if administered with cold needles, we will measure antibody response to influenza vaccine. Blood will be drawn immediately following the administration of the intramuscular injections and pain scoring from a subset of study participants. Sub-study participants will return in 2-4 weeks for a second blood draw to measure post-immunization antibody concentrations.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Healthy adults

Exclusion Criteria:

  • Immunosuppressive medications or medical conditions
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00213967

Sponsors and Collaborators
University of Wisconsin, Madison
Principal Investigator: Mary S Hayney, PharmD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: Mary S. Hayney, PharmD, University of Wisconsin Identifier: NCT00213967     History of Changes
Other Study ID Numbers: 2005-0247
Study First Received: September 13, 2005
Last Updated: January 14, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
Influenza vaccine processed this record on November 19, 2014