Effect of Premedicant Oral Paracetamol on Gastric Volume and pH

NCT ID: NCT04625608

Last Updated: 2021-02-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-06
• Study Completion Date: 2021-12-31

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.

Detailed 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.

Conditions

Fasting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard care

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.

Group Type: OTHER

Standard care

Intervention Type: OTHER

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

Paracetamol arm

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.

Group Type: EXPERIMENTAL

Paracetamol

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Standard care

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 44 Weeks
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Barts & The London NHS Trust

OTHER

Sponsor Role: collaborator

King's College Hospital NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emily Saffer, MB BS

Role: PRINCIPAL_INVESTIGATOR

King's College Hospital NHS Trust

Locations

King's College Hospital

London, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Emily Saffer, MB BS

Role: CONTACT

emily.saffer@nhs.net

+4420 3299 9000

Dominic PD Nielsen, MB ChB

Role: CONTACT

dominic.nielsen1@nhs.net

02073777000

Facility Contacts

Emily Saffer, MB BS

Role: primary

emily.saffer@nhs.net

02032999000

References

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.

Reference Type: BACKGROUND

PMID: 29700894 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15846750 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 6731893 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26157186 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10320598 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30270047 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35166373 (View on PubMed)

Other Identifiers

266252

Identifier Type: -

Identifier Source: org_study_id