Safety of Acupuncture and Intracutaneous Needles in Pediatric Cancer Patients: a Retrospective Study (ACUSAFE2021)

Fundació Sant Joan de Déu

Status: Completed

Conditions: Cancer Pediatric; Thrombocytopenia; Neutropenia; Bacteremia; Safety Issues; Infection;Skin;Localised

Treatments: Procedure: acupuncture

Study type: Observational

Funder types: Other

Identifiers

NCT05585463

PS-14-22

Details and patient eligibility

About

This study aims to demonstrate the safety of intracutaneous needles in pediatric cancer patients. For this, a two-year retrospective study will be carried out to determine the incidence of adverse effects related to acupuncture and the use of intracutaneous needles in the patient in active treatment and survivor.

Full description

Retrospective study of review of medical records. It is a single-center, descriptive, observational study. There are no comparison or control groups. No type of patient selection (randomization or blinding) will be performed.

The medical records of patients treated at the Integrative Pediatric Oncology Unit from September 2019 to September 2021 who have received acupuncture treatment (disposable intracutaneous needles) will be reviewed.

The number of treatments applied, the localization of the treatment, the average number of sessions per patient, and the total number of intracutaneous needles and punctured needles from September 2019 to September 2021. Likewise, the blood cultures and other adverse effects will be reviewed up to 72 hours after the removal of the needles and the intracutaneous needles (Seirin New Pyonex Press Tack®).

Enrollment: 460 patients

Sex: All

Ages: 1 day to 34 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pediatric oncology patients from September 2019 to September 2021 who have received treatment with acupuncture.
• Pediatric oncology patients from September 2019 to September 2021 who have received treatment with intracutaneous needles (Pyonex).

Exclusion criteria

• Pediatric oncology patients who have not received treatment with acupuncture or intracutaneous needles.

Trial design

460 participants in 1 patient group

Oncology pediatric patients treated with acupuncture

Description:

Patients in the oncology area of the Sant Joan de Déu Hospital treated at the UOPI (Integrative Pediatric Oncology Unit) from September 2019 to September 2021 have received treatment with acupuncture and intracutaneous Seirin New Pyonex Press Tack®. Patients in active treatment and survivors are included. Acupuncture treatment can be received in a hospitalization ward, an intensive care unit, a day hospital or an outpatient clinic.

Treatment:

Procedure: acupuncture