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Colic clinical trials

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NCT ID: NCT05052476 Completed - Colic Clinical Trials

First Line Dose-efficacy Study of Bactecal® D Liquid for Infant Colic

BACTECOLIC
Start date: April 8, 2022
Phase: N/A
Study type: Interventional

This randomized, open label, dose-response study will be realized at the first line with Bactecal® D Liquid. The objective is to investigate Bactecal® D Liquid in the context of infantile colics. The patients will be randomized into two arms, A and B, in function of the intervention dose. The quality of life of te parents as well as the daily median crying time and the number of daily crying will be assessed.

NCT ID: NCT04944628 Completed - Clinical trials for Functional Gastrointestinal Disorders

Observational Prospective Study With Probiotic Supplementation on Infants With FGDI

Start date: August 15, 2018
Phase:
Study type: Observational

This observational prospective study evaluates the safety, tolerability and efficacy of a probiotic formula in infants with functional gastrointestinal disorders (FGDI)

NCT ID: NCT04632888 Completed - Self Efficacy Clinical Trials

The Effect of Telephone Support for Breastfeeding Follow-up on Infantile Colic and Maternal Breastfeeding Self-efficacy

Start date: October 14, 2020
Phase: N/A
Study type: Interventional

This study was planned to examine the effect of telephone support for breastfeeding follow-up on physiological jaundice, exclusive breastfeeding in the first six months, infantile colic, maternal breastfeeding self-efficacy, and breastfeeding success.

NCT ID: NCT04487834 Completed - Infantile Colic Clinical Trials

Effects of Vivatlac Baby on Crying Behavior of Colicky Babies

Start date: April 16, 2020
Phase: Phase 2
Study type: Interventional

Open trial with two parallel arms, assessing the effects of Simethicone and Vivatlac Baby in babies diagnosed for infantile colic.

NCT ID: NCT04441762 Completed - Acute Renal Colic Clinical Trials

Atomized Intranasal Vs Intravenous Ketorolac in Acute Renal Colic Pain Management.

Ink-Arc
Start date: December 30, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

Introduction: Pain is a common reason for individuals to seek health care, especially emergency care. Ketorolac has numerous advantages over other pain medications, especially the opioids. The intranasal administration of ketorolac has been shown to be safe and effective in the treatment of postoperative pain following major abdominal surgery and post dental surgery, but there have been no studies evaluating the use of intranasal ketorolac for the treatment of acute renal colic pain in the emergency department. Methods: This is a double blinded randomized controlled trial. two hundred renal colic patients presented to the emergency department will be randomized to intervention (30 mg intranasal ketorolac) and (30mg intravenous ketorolac) case groups. Their pain before and after receiving ketorolac will be measured by visual Analog Scale (VAS pain score). Patient, attending physician and administering nurse will be blinded throughout the study. The analgesic effects will be assessed by several measures including pain relief, pain intensity difference, global pain evaluation, global assessment of analgesia, and the summed pain intensity difference. The safety will be assessed by documentation of adverse events, vital signs, and clinical assessment before and after drug administration. Aim: The aim of this study is to compare analgesic effects of intranasal Ketorolac tromethamine versus intravenous Ketorolac tromethamine in adult patients with moderate to severe renal colic. Primary Objective: Analgesic effects of Intranasal Ketorolac on the visual analog scale (VAS). Secondary Objectives: Adverse Events, the need of rescue pain medications, time to discharge and recurrent visit within 24 hours. Patient Population: Adults (from age 18 to 64 years) who presents to emergency department (ED) at Sultan Qaboos University Hospital with moderate to severe acute flank pain suggestive of renal colic (visual analog scale 7 or more). Intervention: Single dose of intranasal ketorolac 30mg. Clinical measurement: Visual Analog Scale will be assessed at 0, 30 and 60 minutes after intervention. Number and dosage of rescue medication, any reported events by patient or attending physician will be documented. Outcome: Decrease in pain measures by VAS pain score after intranasal ketorolac is given, tolerability and safety evaluation.

NCT ID: NCT04374955 Completed - Clinical trials for Microbial Colonization

The Effect of Probiotic Added to Maternal Diet on Infantile Colic and Intestinal Microbiota Content

Start date: October 7, 2020
Phase: N/A
Study type: Interventional

This study aims to investigate the effect of probiotic added to the diet of mothers on infantile colic in the postpartum period and the content of the neonatal intestinal microbiota.

NCT ID: NCT04286737 Completed - Infantile Colic Clinical Trials

The Effect of Therapeutic Touch on Colic Symptoms in Infantile Colic Infants: A Randomized Controlled Study

Start date: March 2, 2020
Phase: N/A
Study type: Interventional

Aim: The purpose of this study is to determine the effect of therapeutic touch applied to infants with infantile colic on infant colic scale score, crying and sleep time. Method: The study will be conducted as a single-blind, randomized controlled trial. The population of the study will be infants who come to the Pediatrics Outpatient Clinic and are diagnosed as infantile colic according to the evaluation of the pediatrician and have no other health problems. The infants will be divided into two groups as intervention and control groups according to stratified block randomization in the computer environment. After the randomization, therapeutic touch will be applied to the intervention group. No method will be applied to the control group.

NCT ID: NCT04262648 Completed - Constipation Clinical Trials

Randomized Placebo-controlled Study of L. Reuteri NCIMB 30351 in GI Functional Disorders and Food Allergy in Newborns

Start date: March 3, 2020
Phase: N/A
Study type: Interventional

This study is a randomized, placebo-controlled, single-masked (blinded), post-marketing clinical study of a drug Lactobacillus Reuteri NCIMB 30351 drops in functional disorders of gastrointestinal tract and skin symptoms of food allergies in children between the ages of one and four months inclusive. The aim of the study is to assess clinical effects of probiotics Lactobacillus Reuteri NCIMB 30351 drops on the symptoms of infantile colic, constipation, diarrhea, gastroesophageal reflux, atopic dermatitis/eczema in full-term newborns during the first months of life, laboratory parameters of microbiome will also be assessed. A prospective study comparing two treatment groups: Group 1 (treatment group) - 60 infants. Group 2 (control group) - 30 infants, placebo. The study drug will be taken in 1 time per day within 25 days. Allowed symptomatic therapy includes defoamers (simethicone-based preparations), carminative preparations (dill water (fennel)), etc.

NCT ID: NCT04209439 Completed - Renal Colic Clinical Trials

Analgesic Effect of Erector Spinae Plane Block for Renal Colic Pain

Start date: January 1, 2019
Phase: Phase 4
Study type: Interventional

Plane blocks have become very popular in recent years with the introduction of ultrasonography into the regional anesthesia and algology practice. Erector spinae plane (ESP) block involves the injection of local anesthetics between erector spinae muscles and transverse process of vertebrae and can block the dorsal and ventral rami of thoracolumbar spinal nerves. The aim of this study was to evaluate the analgesic efficacy of the erector spine plane block for reno-ureteral colic.

NCT ID: NCT04160520 Completed - Renal Colic Clinical Trials

Pramipexole and Morphine for Renal Colic

Start date: October 28, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

Opioid analgesics are among the most commonly prescribed class of medications in the US. While opioids may effectively control pain and other sensory disorders under acute conditions, the rates of misuse/abuse and accidental overdose have reached epidemic proportions. Clinicians are being challenged to find alternatives to opioid analgesics, or to reduce their use in treating pain whenever possible. Pre-clinical studies have shown that combining morphine (opioid drug) with pramipexole (dopamine 3 receptor agonist with some D2/D4 action) provides superior analgesia against painful stimuli than morphine alone. This analgesia is maintained even when the dose of morphine is lowered to a dose that is not effective on its own. A recent case report describes the use of this combination to restore pain control in a patient with restless legs syndrome, for which opioids alone have lost their effectiveness (Happe S, Clemens S and Brewer KL, In Review). This application proposes to establish a new therapeutic approach for treatment of a pain associated with renal colic (a common painful condition) using a novel combination of 2 existing, FDA-approved drugs. The immediate goal is to demonstrate that this drug combination can provide similar analgesia to opioid alone, and that analgesia is maintained when the opioid dose is reduced by 50%.