20 mls of Chloroprocaine Hcl 2% Inj (1 vial containing 400mg/20 mls of chloroprocaine) will be instilled into the abdomen prior to fascia closure.

20 mls of normal saline will be instilled into the abdomen prior to fascia closure.

Cesarean Section Complications

Pain

Chloroprocaine Hcl 2% Inj

Normal saline

Intraabdominal Chloroprocaine During Cesarean Delivery for Pain Control

An Evaluation of Intraabdominal Chloroprocaine During Cesarean Delivery and Its Effect on Postoperative Pain and Nausea; a Randomized Controlled Trial & Pharmacokinetic-pharmacodynamics (PKPD) Analysis.

Our primary outcome measure will be postoperative pain as measured by visual analogue scale (VAS) at 1 hours after skin closure (sitting in an upright position and movement of lower extremities) after cesarean section. The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient selects a whole number (0-10 integers) that best reflects the intensity of their pain, with 0 being the best pain and 10 being the worst pain.

Visual analogue scale (VAS) at 2, 6, 24 and 48 hours at rest and during mobilization. The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient selects a whole number (0-10 integers) that best reflects the intensity of their pain, with 0 being the best pain and 10 being the worst pain.

An adverse effect is an undesired harmful effect resulting from chloroprocaine use. Adverse effects of chloroprocaine include gastrointestinal (nausea, vomiting), dizziness, rash, itching, redness and anxiety.

The patients will be evaluated for increased analgesic requirement after use of chloroprocaine or placebo. The total amount of analgesia used will be recorded.

A hospital readmission for pain is an episode when a patient who had been adequately pain controlled is discharged from a hospital is admitted again within a specified time interval for poor pain control.

This is defined as the number of days the patient stays in the hospital after cesarean section.

No personal patient data will be shared with other researchers. The final de-identified manuscript will be published.

Johns Hopkins University

Patients admitted for cesarean section and meeting inclusion criteria will be approached for consent. Consented patients will then be randomized into two groups.
Group 1: (intraabdominal chloroprocaine administration): These participants will have intraabdominal chloroprocaine administration at the time of cesarean section before fascial closure.
Group 2: (Intraabdominal instillation of placebo (sterile water): These participants will have placebo (normal saline) administered at the time of cesarean section before fascial closure. Cesarean section will proceed traditionally, including fascial and skin closure.

The investigator and patients will be masked from the treatment options. The care providers will not be masked.

One or more oral thin films (OTFs) containing potassium acid phosphate administered to the inside cheek, tongue or palate at a dose of 0.5 mmol/kg body weight twice daily. Dosages will be rounded to the nearest 0.1 mM/kg. Where more than one OTF is required to achieve a dosage of 0.5mmol/kg, strips will be administered consecutively with time allowed between doses to allow for complete dissolving of the previous strip. Treatment will continue until the participant has received OTF therapy for 14 consecutive days.

Standard oral phosphate supplementation as per NHS Greater Glasgow and Clyde Guidelines. An oral solution containing potassium acid phosphate (1 mmol/mL) will be administered at a dosage of 0.5 mM/kg body weight twice daily. Dosages will be rounded to the nearest 0.1 mM/kg. Standard therapy will continue until the participant has received treatment for 14 consecutive days.

Hypophosphataemia

Osteopenia of Prematurity

Orally dissolving thin film. White, square oral thin film. 15 mm x 15 mm surface area. 1-2 mm film thickness. No markings.
Place a single OTF on the tongue, inside cheek or palate and allow to dissolve.

Oral thin film therapy (Potassium acid phosphate oral thin films)

Each millilitre contains approximately 136mg Monobasic Potassium Phosphate Ph.Eur. (KH2PO4) equivalent to 1mmol Potassium (39mg) and 1mmol Phosphate (31mg Phosphorus). Manufacturer: Specials Products Ltd., Surrey, UK.

Standard therapy (Potassium acid phosphate oral solution)

Princess Royal Maternity

Investigating a New Way of Giving Medicine to Newborn and Preterm Babies

Oral Potassium Acid Phosphate Supplementation for Preterm Neonates; a Comparison of Oral Thin Films and Standard Oral Therapy.

The aim of this research is to demonstrate that oral thin films (OTFs) containing potassium acid phosphate are equivalent to standard oral phosphate supplementation using an oral solution in the prevention of hypophosphataemia (low blood phosphorus). The primary outcome measure will be plasma phosphate. We will assume an equivalent therapeutic effect using OTFs if individual plasma levels for these babies are found to lie within an acceptable physiological range, and the difference between the means of the two groups (as determined by a statistical t-test) lies within 20% of the mean plasma level for the control group.

Secondary objectives will be in terms of age-appropriateness and general acceptability. A lack of any observable adverse effects e.g. choking, vomiting, diarrhoea, will indicate the safety of oral thin films in this age group. Acceptability will be assessed in terms of observed discomfort/distress e.g. grimacing, crying, associated with treatment administration and will be assessed using visual analogue scales.

benzoic/kvalme

Intraabdominal Chloroprocaine During Cesarean Delivery for Pain Control

Investigating a New Way of Giving Medicine to Newborn and Preterm Babies

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