Pain Clinical Trial - Vaccine‐Related Pain in Infants

Status Completed

Clinical Trial Summary

This is a randomized double-blind controlled study and was performed to compare effects of rapid injection without aspiration and 10-second manual pressure before injection on pain severity and crying time in 4-6-month-old infants given the vaccine DTaP/IPV/Hib.

The study population included all the infants presenting for DTaP/IPV/Hib to two family health centers between April and August in 2015. The study sample included 128 infants based on confidence interval of 95% and statistical power of 80%. The sample was divided into four groups; i.e. manual pressure, rapid injection without aspiration, manual pressure combined with rapid injection without aspiration and control groups. There were 32 infants in each group. Gender was adjusted in all groups. Stratified and block randomizations were used.

Clinical Trial Description

Study design: this is an experimental, double-blind, randomized controlled trial.

Study population and study sample: The study was conducted in two family health centers of Cankiri Public Health Directorate, Turkey, between April and August in 2015. The study population included infants aged 4-6 months and presenting to the family health centers for the second and third doses of DTaP/IPV/Hib. The study sample comprised of 128 infants based on confidence interval of 95% and statistical power of 80%. Analysis made at the end of the study showed a statistical power of 0.83 based on confidence interval of 95%.

Outcome Measures

Pain severity: Video recordings obtained were evaluated by two pain specialists separately by using Neonatal Infant Pain Scale. The specialists were blinded to the groups to eliminate possible mistakes in observations and the possibility of taking sides and to avoid bias. The scores assigned by the specialists were used to determine pain scores before, during and after vaccine injections.

Crying time: Video recordings taken were watched by the same researcher and crying time before, during and after vaccine injections was calculated for each infant.

Physiological Changes (heart rate and oxygen saturation): the probe of pulse oximetry was attached to the foot not injected vaccine to measure oxygen saturation and heart rate before, during and after the injections in each child. ;

Study Design

Allocation: Randomized, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Pain

Clinical Trial Details

NCT number	NCT02808637
Study type	Interventional
Source	Çankiri Karatekin University
Contact
Status	Completed
Phase	N/A
Start date	April 2015
Completion date	January 2016

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05559255` - Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI	N/A
Completed	`NCT04748367` - Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care	N/A
Terminated	`NCT04356352` - Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain	Phase 2/Phase 3
Completed	`NCT05057988` - Virtual Empowered Relief for Chronic Pain	N/A
Completed	`NCT04466111` - Observational, Post Market Study in Treating Chronic Upper Extremity Limb Pain
Recruiting	`NCT06206252` - Can Medical Cannabis Affect Opioid Use?
Completed	`NCT05868122` - A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy	Phase 3
Active, not recruiting	`NCT05006976` - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study	N/A
Completed	`NCT03273114` - Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain	N/A
Enrolling by invitation	`NCT06087432` - Is PNF Application Effective on Temporomandibular Dysfunction	N/A
Completed	`NCT05508594` - Efficacy and Pharmacokinetic-Pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001	Phase 2/Phase 3
Recruiting	`NCT03646955` - Partial Breast Versus no Irradiation for Women With Early Breast Cancer	N/A
Active, not recruiting	`NCT03472300` - Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
Completed	`NCT03678168` - A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries	N/A
Completed	`NCT03286543` - Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System	N/A
Completed	`NCT03931772` - Online Automated Self-Hypnosis Program	N/A
Completed	`NCT02913027` - Can We Improve the Comfort of Pelvic Exams?	N/A
Terminated	`NCT02181387` - Acetaminophen Use in Labor - Does Use of Acetaminophen Reduce Neuraxial Analgesic Drug Requirement During Labor?	Phase 4
Recruiting	`NCT06032559` - Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment	Phase 3
Active, not recruiting	`NCT03613155` - Assessment of Anxiety in Patients Treated by SMUR Toulouse and Receiving MEOPA as Part of Their Care

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.