Effect of Premedicant Oral Paracetamol on Gastric Volume and pH

Fasting Clinical Trial

Official title:

A Randomised Controlled Trial Examining the Effect of Premedicant Oral Paracetamol on Gastric Residual Volume and pH in Children, in the Context of a 1-hour Clear Fluid Fast

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04625608
• Other study ID #: 266252
• Status: Recruiting
• Phase: Phase 4
• Start date: October 6, 2020
• Est. completion date: December 2021

Study information

• Verified date: February 2021
• Source: King's College Hospital NHS Trust
• Contact: Emily Saffer, MB BS
• Phone: +4420 3299 9000
• Email: emily.saffer[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients are asked to fast before general anaesthesia to reduce the risk that any gastric contents could be regurgitated and aspirated into the lungs once anaesthetised. If aspiration does occur, the volume and acidity of the fluid aspirated are thought to determine the extent of any harm caused. Recent guidelines have reduced the required fasting time for children for clear fluids from 2 hours to 1 hour before induction of anaesthesia, as it is understood that this does not adversely affect the gastric residual volume or increase its acidity. Paracetamol is commonly used to relieve pain during and after surgery. Paracetamol syrup preparations used in children are viscous and not classified as clear fluid. This study seeks to establish whether there is non-inferiority in gastric residual volume (GRV) and pH in children receiving oral paracetamol one hour before induction of anaesthesia and those who do not, when both groups have received a set volume of diluted orange cordial to drink. It is anticipated that if shown to have little or no impact on GRV and pH, oral paracetamol syrup can be given to children before surgery. This will omit the need for IV paracetamol to be given in theatre, potentially reducing cost and the risk of drug errors.

Description:

Patients are asked to fast before anaesthesia to reduce the risk that residual gastric contents could be regurgitated and aspirated into the lungs once anaesthetised. In animal studies, gastric contents that are less acidic (with a pH >1.8) have been shown to be less harmful when aspirated than those that are more acidic, even at higher gastric residual volumes. Recent European and UK guidelines have reduced the length of the recommended clear fluid fast to 1 hour for children, as there is no significant difference in GRV or pH in children fasted for 1 hour compared to 2 hours. It is therefore believed to present no additional risk of harm. Some anaesthetists administer oral paracetamol syrup to children pre-operatively as an alternative to intravenous administration of paracetamol during their surgery. The oral route has been suggested to be pleasant for children, cheaper, more convenient, and reduce the risk of drug errors associated with the IV preparation. Anderson et al found no significant difference in gastric volume or pH in children with a mean age of 8.5 years given paracetamol orally 90 minutes before surgery compared to children given paracetamol rectally. Burke et al. demonstrated that giving paracetamol orally up to 8 minutes before induction of anaesthesia was not associated with an increase in the volume of stomach contents, and that the pH of stomach contents was higher than in control subjects who did not receive paracetamol. This suggests that giving oral paracetamol before induction of anaesthesia may not present any increased risk of harm from aspiration. This was in the context of a mean fluid fast of 5 hours and a mean age of 5.1 years. To our knowledge, no studies have assessed the effect of oral paracetamol syrup on gastric residual volume (GRV) and pH in the context of the newly recommended reduced clear fluid fasting time of 1 hour. Neither has this been studied in children as young as 44 weeks post-conceptual age.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: December 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 44 Weeks to 8 Years

Eligibility

Inclusion Criteria:

• Elective surgery
• Requiring tracheal intubation for general anaesthesia
• Parent/guardian able to speak and understand written English

Exclusion Criteria:

• Known or suspected gastro-intestinal disease including varices
• Previous surgery which may alter gastric emptying or the anatomy of the oesophagus or stomach
• Anticipated difficult airway
• Concomitant administration of any other medication orally prior to anaesthesia, but excluding buccal sedative pre-medication eg midazolam
• Bleeding disorders
• Patients taking antacids or pro-kinetic drugs, or requiring them pre-operatively
• Allergy to paracetamol
• Patient weight greater than 25 kg
• Parental or patient refusal

Related Conditions & MeSH terms

• Fasting

Intervention

Drug:
• Paracetamol
Standard care of 3 ml/kg water, plus 15 mg/kg oral paracetamol suspension, a minimum of 1 hour prior to the induction of general anaesthesia.

Other:
• Standard care
Standard care of 3.6 ml/kg water, a minimum of 1 hour prior to the induction of general anaesthesia.

Locations

Country	Name	City	State
United Kingdom	King's College Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
King's College Hospital NHS Trust	Barts & The London NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (6)

Anderson BJ, Rees SG, Liley A, Stewart AW, Wardill MJ. Effect of preoperative paracetamol on gastric volumes and pH in children. Paediatr Anaesth. 1999;9(3):203-7. — View Citation

Brady M, Kinn S, O'Rourke K, Randhawa N, Stuart P. Preoperative fasting for preventing perioperative complications in children. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD005285. Review. Update in: Cochrane Database Syst Rev. 2009;(4):CD005285. — View Citation

Burke CN, D'Agostino R, Tait AR, Malviya S, Voepel-Lewis T. Effect of Preemptive Acetaminophen Administered Within 1 Hour of General Anesthesia on Gastric Residual Volume and pH in Children. J Perianesth Nurs. 2019 Apr;34(2):297-302. doi: 10.1016/j.jopan.2018.05.015. Epub 2018 Sep 27. — View Citation

James CF, Modell JH, Gibbs CP, Kuck EJ, Ruiz BC. Pulmonary aspiration--effects of volume and pH in the rat. Anesth Analg. 1984 Jul;63(7):665-8. — View Citation

Jibril F, Sharaby S, Mohamed A, Wilby KJ. Intravenous versus Oral Acetaminophen for Pain: Systematic Review of Current Evidence to Support Clinical Decision-Making. Can J Hosp Pharm. 2015 May-Jun;68(3):238-47. Review. — View Citation

Thomas M, Morrison C, Newton R, Schindler E. Consensus statement on clear fluids fasting for elective pediatric general anesthesia. Paediatr Anaesth. 2018 May;28(5):411-414. doi: 10.1111/pan.13370. Epub 2018 Apr 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events at induction of anaesthesia	Adverse events occurring around the time of induction of anaesthesia including regurgitation and aspiration of gastric contents	Up to 10 minutes after the induction of anaesthesia
Other	Adverse events at emergence from anaesthesia	Adverse events occurring around the time of emergence from anaesthesia including regurgitation and aspiration of gastric contents	Up to 10 minutes from removal of the patient's airway
Other	Paracetamol drug errors	Paracetamol related drug errors	For day case patients, until discharge. For inpatients, up to 24 hours post-operatively.
Other	Emergence delirium	Incidence of emergence delirium in post-anaesthesia care unit, measured with PAED score.	Up to 10 minutes following patient arrival in PACU.
Other	Adverse events in Post-Anaesthesia Care Unit	Adverse regurgitation or aspiration events occurring in the post-anaesthesia care unit, including requirements for additional analgesia, time to first analgesic request and time spent in the post-anaesthesia care unit.	From arrival in the post-anaesthesia care unit until patient is ready for discharge to the ward, up to 24 hours.
Primary	Residual volume of gastric contents following induction of general anaesthesia	Gastric volume and pH of that fluid that can be aspirated via an oro-gastric tube, passed into the patient's stomach once general anaesthesia has been induced and the airway secured.	Approximately 5-10 minutes following the induction of general anaesthesia.
Primary	pH of gastric contents following induction of general anaesthesia	Gastric volume and pH of that fluid that can be aspirated via an oro-gastric tube, passed into the patient's stomach once general anaesthesia has been induced and the airway secured.	Approximately 5-10 minutes following the induction of general anaesthesia.