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

NCT ID: NCT06390007

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-12
• Study Completion Date: 2025-04-23

Brief Summary

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.

Conditions

Pain, Postoperative; Pediatric Disorder; Acupuncture; Acupuncture, Ear; Pediatric Intensive Care Unit

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control group

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.

Group Type: PLACEBO_COMPARATOR

Sham press needle

Intervention Type: DEVICE

The plester used is a round plaster that resembles the shape of an acupuncture press needle.

Intervention group

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

Group Type: EXPERIMENTAL

Press needle acupuncture

Intervention Type: DEVICE

Press needle acupuncture is a modality of acupuncture using tiny and very thin needles.

Interventions

Sham press needle

The plester used is a round plaster that resembles the shape of an acupuncture press needle.

Intervention Type: DEVICE

Press needle acupuncture

Press needle acupuncture is a modality of acupuncture using tiny and very thin needles.

Intervention Type: DEVICE

Other Intervention Names

plesterin

Eligibility Criteria

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Dr. dr. Irene Yuniar, Sp.A(K)

Lecturer of Indonesia University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

RSUPN Dr. Cipto Mangunkusumo

Jakarta Pusat, DKI Jakarta, Indonesia

Countries

Indonesia

Other Identifiers

24916

Identifier Type: -

Identifier Source: org_study_id