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NCT Number: NCT06390007

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

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.

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Key information

Conditions

Pain, Postoperative Acupuncture Acupuncture, Ear Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pediatric Disorder Pediatric Intensive Care Unit Perceptual Disorders Postoperative Complications Signs and Symptoms

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RSUPN Dr. Cipto Mangunkusumo

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sham Press Needle

Device

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

Other names: plesterin

Press needle acupuncture

Device

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

Primary outcomes

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

    Time frame: 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

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

  2. Numeric Rating Scale (NRS) pain scale

    Time frame: 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

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

  3. Behavioral Pain Scale (BPS)

    Time frame: 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

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

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

The Efficacy of Acupuncture in the Management of Postoperative Pain in the Pediatric Intensive Care Unit at Cipto Mangunkusumo Hospital

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 29, 2024
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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