The Effect of ShotBlocker in Reducing Pain Associated with Peripheral Intravenous Cannulation in School Age Children: A Randomized Controlled Trial (RCT)

To compare the efficacy of ShotBlocker and ShotBlocker placebo in reducing pain during intravenous cannulation (IV) in School Age Children(6-12 years).

Comparative,randomized, controlled clinical trial with parallel group design of 192 patients.

This study was conducted in the emergency room of three Wasit hospitals, where the study included 192 patients who entered the emergency department and needed intravenous cannulation. They were divided into three groups and the study was conducted on them.

The inclusion criteria: Consent to volunteer to participate in the study. Being between the ages of 6 and 12 years. Intravenous cannulation will be applied in right and left hand only. No difficulty in communication, including hearing, visual, speech, and language problems. Not receiving oral or parenteral analgesic treatment before administration. Not receiving chemotherapy treatment. The exclusion criteria: Skin conditions such as burns, rashes, open wounds, abscess or boil, severe local infection or cellulitis at the intended insertion site. Peripheral vascular disease or compromised peripheral circulation at the intended insertion site (e. g. Peripheral neuropathy, diabetes, Peripheral artery disease, Raynaud's disease). Blood clotting disorders or increased risk of bleeding (e.g., hemophilia, thrombocytopenia). Anatomical abnormalities or restrictions that impede proper insertion or cause increased risk of complications. History of injections during the last 3 months.

This stage begins with intravenous cannulation injection first using a shotblocker or a shotblocker placebo , then ask the patient about the severity of the pain by using Wong-Baker Faces pain scale, and then write the answer on the questionnaire sheet.

Reducing pain during intravenous cannulation

In order to maintain a transparent & scientific-based randomization process, simple randomization will be used in assigning participants to 2 intervention & control groups, assuming that each participant has an equal chance of being assigned to any group. The simple randomization procedure would involve throwing a dice (eg, below & equal to 3 = control, over 3 =treatment). No allocation concealment will be carried out.

Blinding description refers to the process of concealing certain information from participants or researchers in a study or experiment. This is typically done to minimize bias and ensure the integrity of the results. In the context of a randomized control trial, blinding refers to keeping participants and/or researchers unaware of certain details, such as the treatment assignment or the group to which participants belong (e.g., experimental group or control group). This helps to ensure that the study's outcomes are not influenced by expectations or preferences, and that the results are more reliable and objective.

The researcher is acknowledging the scientific community to have verifiable findings of the study. sharing plan includes making all the related data available through publishing the study report in peer-reviewed reputable journals

God willing, once finishing the process of data collection, analysis and successfully publishing the manuscript, all the related files will become available for 6 months after publications

All the related files will be shared with any scientific interested parties.

It may be used after seeking the author's permission and acknowledging his contribution.

The author's professional e-mail that will be available with the published manuscript can be used to contact the author. e-Mail: salsabeel.alaa2204m@conursing.uobaghdad.edu.iq

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Profound appreciations are due to the IRCT members for their genuine efforts in helping researchers fulfilling their academic endeavors.