The Efficacy of Acupuncture in the Management of Postoperative Pain in the Pediatric Intensive Care Unit

University of Indonesia (UI)

Status: Not yet enrolling

Conditions: Pediatric Disorder; Pain, Postoperative

Treatments: Device: Press needle acupuncture; Device: Sham press needle

Study type: Interventional

Funder types: Other

Identifiers

NCT06390007

24916

Details and patient eligibility

About

Pain is an unpleasant sensory and emotional experience resulting from tissue damage. Pain management is typically conducted according to the World Health Organization (WHO) pain management ladder. Analgesics administered to pediatric patients vary in dosage and type, but these analgesics often have significant side effects. The acupuncture technique using press needles is a non-pharmacological pain therapy modality that has been studied for its ability to reduce the use of analgesic drugs, thereby potentially decreasing side effects associated with analgesic use.

The study was conducted using a randomized controlled trial (RCT) design involving 70 pediatric postoperative patients aged 1-18 years who were admitted to the Pediatric Intensive Care Unit at Cipto Mangunkusumo Hospital. Subjects were divided into two groups: a control group and an experimental group. The control group received standard analgesic therapy and sham press needle application (a patch resembling a press needle without a needle), while the experimental group received standard analgesic therapy and press needle application at acupuncture points after the patient had been in the Pediatric Intensive Care Unit for 24 hours. Pain scale monitoring was conducted at 1, 6, 24, 48, and 72 hours using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale for children aged 1-8 years, and the Numeric Rating Scale (NRS) for children over 8 years old.

This study hypothesizes that the acupuncture technique using press needles can reduce the pain scale in pediatric postoperative patients, leading to a decrease in the use of analgesics and a reduction in side effects associated with analgesic use.

Enrollment: 70 estimated patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pediatric postoperative patients admitted to the Pediatric Intensive Care Unit at Cipto Mangunkusumo Hospital
• Aged between 1 and 18 years
• Patients with a platelet count greater than 20,000/mL
• Patients undergoing elective surgery
• Willingness to participate in the study

Exclusion criteria

• Patients with a local infection at the puncture site
• Patients with anatomical abnormalities of the outer ear
• Failure to complete the acupuncture therapy
• Patients with chronic illnesses who have previously received analgesic therapy

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

In the control group, standard analgesic therapy will be administered by the attending physician, and a sham press needle (a patch resembling a press needle without a needle) will be applied.

Treatment:

Device: Sham press needle

Intervention group

Experimental group

Description:

In the experimental group, standard analgesic therapy will be administered and press needle acupuncture will be applied at acupuncture points.

Treatment:

Device: Press needle acupuncture