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

NCT06390007 | Completed DMC

• 1 other identifier: 24916
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Keywords

Acupuncture; Postoperative pain; Pediatric Intensive Care Unit; Press needle; Pain therapy

Outcome Measures

Primary Outcomes (3)

• Face, Legs, Activity, Cry, and Consolability (FLACC) pain scale

  The Face, Legs, Activity, Cry, and Consolability (FLACC) pain scale for children aged 1 to 8 years is used to assess pain levels

  Pain scale monitoring will be conducted at 1 hour; 6 hours; 24 hours; 48 hours; and 72 hours after the application of sham press needle / press needle acupuncture

• Numeric Rating Scale (NRS) pain scale

  The Numeric Rating Scale (NRS) is used to assess pain levels in children over the age of 8.

  Pain scale monitoring will be conducted at 1 hour; 6 hours; 24 hours; 48 hours; and 72 hours after the application of sham press needle / press needle acupuncture

• Behavioral Pain Scale (BPS)

  The Behavioral Pain Scale (BPS) with a range of 3 to 12 for patients on ventilators.

  Pain scale monitoring will be conducted at 1 hour; 6 hours; 24 hours; 48 hours; and 72 hours after the application of sham press needle / press needle acupuncture

Study Arms (2)

Control group

PLACEBO COMPARATOR

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.

Device: Sham press needle

Intervention group

EXPERIMENTAL

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

Device: Press needle acupuncture

Interventions

Sham press needle DEVICE

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

Also known as: plesterin

Control group

Press needle acupuncture DEVICE

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

Intervention group

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

RSUPN Dr. Cipto Mangunkusumo

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Indonesia University

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: April 29, 2024
• Study Start: September 12, 2024
• Primary Completion: March 22, 2025
• Study Completion: April 23, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)