In this Group will be enrolled only infants who are breastfed. This Group will take the active product containing 5 drops of active product (108 viable cells/strain) of Bifidobacterium breve BR03 and Bifidobacterium breve B632.

In this active Group will be enrolled only infant who are bottle-fed. This Group will take the active product containing 5 drops of active product (108 viable cells/strain) of Bifidobacterium breve BR03 and Bifidobacterium breve B632.

In this placebo Group will be enrolled only infants who are breastfed. This arm will receive a supplementation with a same product equal to the active product but without bifidobacterium inside.

In this placebo Group will be enrolled only infants who are bottlefed. This arm will receive a supplementation with a same product equal to the active product but without bifidobacterium inside.

Colic, Infantile

Probiotic

Gut Microbiome

Bifidobacterium Breve

This is the active product containing 108 viable cells/strain

Bifidobacterium breve BR03 and Bifidobacterium breve B632

This is the placebo product containing a similar product without bifidobacterium inside.

Placebos

AOU Maggiore della Carità - Clinica Pediatrica - Ambulatorio di Gastroenterologia Pediatrica

NEOBIFI: Clinical Trial for the Prevention and/or Reduction of the Incidence of Colics in Infants

Effects of an Association of the Two Bifidobacteria Probiotics Bifidobacterium Breve B632 and Bifidobacterium Breve BR03 in Intestinal Bacterial Colonization and in the Prevention and/or Reduction of the Incidence of Colics in Infants

The primary endpoint of the study was the assessment of the effectiveness of B. breve B632 and BR03 association in the reduction of infants crying over time. Both breastfed and bottle-fed babies were studied.

The second endpoint was to observe the effect of these probiotics on daily evacuations and on the number of regurgitations and vomits.

Evaluate any variation of fecal microbiome

Flavia Prodam

Assoc. Professor in Clinical Nutrition

Azienda Ospedaliero Universitaria Maggiore della Carita

During the 90 days of the study, parents were asked to give 5 drops of active product (108 viable cells/strain) or placebo and to daily take note of minutes of crying, number, color, and consistency of evacuations, and number of regurgitations or vomits.

The study is a triple blind study in which the treatment or intervention is unknown to the research participant, the individuals who administer the treatment or intervention, and the researchers who assess the outcomes.

C group (n=20) (placebo group) each patient received transdermal placebo patch, identical placebo patches custom-made by 1-800-Patches (Salt Lake City, UT) placed 2 hours preoperatively for acute postoperative pain after laparoscopic cholecystectomy.

TDN group (n=20) each patient received transdermal therapeutic system- nicotine (15 mg/16 h),Nicorette® invisi 15mg patch releasing 15mg of nicotine over 16h, produced by Lohmann Therapie-System, Germany placed 2 hours preoperatively for acute postoperative pain after laparoscopic cholecystectomy.

TDM group (n=20) each patient received transdermal therapeutic system- melatonin (7 mg/8h),melatonin sleep patch from Respro Labs ™ containing 7 mg of melatonin placed 2 hours preoperatively for acute postoperative pain after laparoscopic cholecystectomy.

Postoperative Pain Relief

Postoperative pain was evaluated based on visual analogue scale, first time to ask for rescue analgesia and total pethidine requirements (mg) in 12 hours postoperatively were also recorded.

Placebo

transdermal therapeutic system- nicotine.

transdermal therapeutic system- melatonin.

Transdermal Nicotine and Melatonin Patches for Postoperative Pain Relief

Comparative Study Between Transdermal Nicotine and Melatonin Patches on Postoperative Pain Relief After Laparoscopic Cholecystectomy, a Double-blind, Placebo-controlled Trial

Dr.Ibrahim Mamdouh Esmat

Ain Shams University

C group, (n=25) each patient received transdermal placebo patch

TDF group, (n=25) each patient received transdermal therapeutic system-fentanyl 50μg/h

TDM group, (n=25) each patient received transdermal therapeutic system containing 7 mg of melatonin

Postoperative Pain

Comparative study between transdermal fentanyl and melatonin patches on postoperative pain relief after lumber laminectomy

Transdermal Fentanyl and Melatonin Patches for Postoperative Pain Relief

Comparative Study Between Transdermal Fentanyl and Melatonin Patches on Postoperative Pain Relief After Lumber Laminectomy, a Double-blind, Placebo-controlled Trial

Melatonin, Vitamin C and placebo tablet Preoperative single oral dose of melatonin (6 mg) or placebo tablet will be given one hour before the start of anesthesia.

Melatonin, Vitamin C and placebo tablet Preoperative single oral dose of vitamin C (2 gr) or placebo tablet will be given one hour before the start of anesthesia.

Preoperative single oral dose of placebo tablet will be given one hour before the start of anesthesia.

Preoperative melatonin tablet will be given and postoperative pain scores will be evaluated

Melatonin

Preoperative vitamin C tablet will be given and postoperative pain scores will be evaluated

Vitamin C

Preoperative placebo tablet will be given and postoperative pain scores will be evaluated

Hakkı Ünlügenç

Preoperative Melatonin or Vitamin C Administration on Postoperative Analgesia

Comparison Of The Effects Of Preoperative Melatonin Or Vitamin C Administration On Postoperative Analgesia

Hakki Unlugenc

Clinical Professor

Cukurova University

Premedication with 3 mg melatonin (Meloset) tablet orally 1-2 hour prior to anesthesia

Premedication with 3 mg melatonin and 0.5 mg alprazolam (Stresnil) tablet orally 1-2 hrs prior to anesthesia

Premedication with 0.5 mg alprazolam (Alprax) tablet orally 1-2 hr prior to anesthesia

Premedication with a similar looking placebo tablet orally 1-2 hr prior to anesthesia

premedication 1-2 hour prior to anesthesia

Melatonin and Alprazolam

Alprazolam

Total

Sex: Female, Male

Region of Enrollment

VAS (Visual Analogue Score) Anxiety Scale is 10 cm long and has the patient's side (front) and the clinician's side (back). The extremes of the front are colored as white and black; with a gradual darkening of color from white to black in between. The back is marked in centimeter from 0 to 10 and 0 correlates with white color (no anxiety at all) and 10 correlates to black color (anxiety as bad as ever can be). The patient is asked to point at the color on the scale according to his anxiety level. As anxiety is worsened, the score is more. The maximum value of assessment is 10 and minimum is 0.

Vas baseline (cm)

Anaesthesia time

VAS (Visual Analogue Score) Anxiety Scale is a 10 cm long scale with two sides, the patient side (front) and the clinicians side (back). The extremes of the front are colored as white and black with a gradual darkening of color from white to black. The back is marked in centimeter from 0 to 10 and 0 correlates with white color (no anxiety at all) and 10 correlates to black color (anxiety as bad as ever can be) on the front. As anxiety is worsened, the color is darker and score is more. The maximum score is 10 and minimum 0. The patient is asked to point on the scale according to his anxiety level. The anxiety score is the correlating number on the clinicians side. The more the reduction in anxiety from baseline, the better the outcome.

Change in VAS Anxiety Score Relative to Baseline After Premedication

Sedation level was assessed with a 5 point scale (0=alert, 1=arouses to voice, 2=arouses with gentle tactile stimulation, 3=arouses with vigorous tactile stimulation, 4=lack of responsiveness). Minimum score is 0 and Maximum is 4. The lesser the score, the better the outcome.

Sedation Score at One Hour After Premedication

Orientation was assessed with a 3 point scale (0=none, 1=orientation in either time or place, 2=orientation in both). Minimum score is 0 and maximum is 2. The lesser the score, the lesser the effect on patients cognition and the better the outcome.

Orientation Score

Number of patients who recalled or recognized the picture number five shown one hour after premedication. The more the number of patients with intact memory, the better the outcome.

Number of Patients With Intact Memory

Dose of propofol needed for loss of response to verbal command was noted at the time of induction of general anesthesia. The lesser the propofol needed for the loss of response to verbal command, the better the outcome.

Amount of Propofol Consumption

Change in VAS Anxiety Score Relative to Baseline at 30 Minutes After Premedication

Change in VAS Anxiety Score Relative to Baseline at One Hour After Premedication

Patients were asked whether they recalled the event of being transferred to the operating room before anaesthesia. The lesser the number of patients with amnesia, the better the outcome.

Number of Patients With Loss of Memory for Being Transferred to Operating Room.

Oral premedication with 3 mg melatonin tablet (Meloset) 1-2 hour prior to anesthesia

Oral premedication with a 3 mg melatonin and 0.5 mg alprazolam combination tablet (Stressnil) 1-2 hrs prior to anesthesia

Oral premedication with 0.5 mg alprazolam (Alprax) 1-2 hr prior to anesthesia

Oral premedication with a similar looking placebo tablet 1-2 hr prior to anesthesia

Overall Study

Dr Krishna Pokharel

Anxiety

3 mg melatonin tablet 1-2 hour prior surgery

meloset (melatonin)

3 mg melatonin and 0.5 mg alprazolam 1-2 hr before anesthesia

melatonin/erbrechen

NEOBIFI: Clinical Trial for the Prevention and/or Reduction of the Incidence of Colics in Infants

Transdermal Nicotine and Melatonin Patches for Postoperative Pain Relief

Transdermal Fentanyl and Melatonin Patches for Postoperative Pain Relief

Preoperative Melatonin or Vitamin C Administration on Postoperative Analgesia

Premedication With Melatonin and Alprazolam Combination Versus Alprazolam or Melatonin Alone

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