Effect of Premedicant Oral Paracetamol on Gastric Volume and pH

NCT04625608 | Unknown Phase 4

• 1 other identifier: 266252
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fasting

Keywords

general anaesthesia; children; paracetamol

Outcome Measures

Primary Outcomes (2)

• 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.

• 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.

Other Outcomes (5)

• Adverse events at induction of anaesthesia

  Up to 10 minutes after the induction of anaesthesia

• Adverse events at emergence from anaesthesia

  Up to 10 minutes from removal of the patient's airway

• Paracetamol drug errors

  For day case patients, until discharge. For inpatients, up to 24 hours post-operatively.

Study Arms (2)

Standard care

OTHER

Participants in this arm shall receive 3.6 ml/kg of water a minimum of 1 hour prior to the induction of general anaesthesia. This is standard practice in the 2 participating institutions.

Other: Standard care

Paracetamol arm

EXPERIMENTAL

Participants in this arm shall receive 3 ml/kg of water plus 15 mg/kg of oral paracetamol suspension a minimum of 1 hour prior to the induction of general anaesthesia.

Drug: Paracetamol

Interventions

Paracetamol DRUG

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.

Paracetamol arm

Standard care OTHER

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

Standard care

Eligibility Criteria

• Age: 44 Weeks - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead
• Barts & The London NHS Trust: collaborator

Study Sites (1)

King's College Hospital

London, SE5 9RS, United Kingdom

RECRUITING

Related Publications (7)

• 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.

  PMID: 29700894 BACKGROUND

• 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. doi: 10.1002/14651858.CD005285.

  PMID: 15846750 BACKGROUND

• 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.

  PMID: 6731893 BACKGROUND

• 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. doi: 10.4212/cjhp.v68i3.1458.

  PMID: 26157186 BACKGROUND

• 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. doi: 10.1046/j.1460-9592.1999.00348.x.

  PMID: 10320598 BACKGROUND

• 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.

  PMID: 30270047 BACKGROUND

• Saffer E, Nielsen DPD, Warwick E, Stilwell A, Webb C, Chow G, Place MK. Effect of pre-operative oral paracetamol on gastric residual volume and pH in young children in the context of a 1-hour clear fluid fast: a randomised controlled trial. Anaesthesia. 2022 Apr;77(4):449-455. doi: 10.1111/anae.15670. Epub 2022 Feb 15.

  PMID: 35166373 DERIVED

MeSH Terms

Conditions

Fasting

Interventions

Acetaminophen; Standard of Care

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Emily Saffer, MB BS

  King's College Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily Saffer, MB BS

CONTACT

+4420 3299 9000; emily.saffer@nhs.net

Dominic PD Nielsen, MB ChB

CONTACT

02073777000; dominic.nielsen1@nhs.net

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: November 12, 2020
• Study Start: October 6, 2020
• Primary Completion: August 1, 2021
• Study Completion: December 1, 2021
• Last Updated: February 21, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)