The efficacy of 50% Nitrous Oxide mixture (Entonox) for Pain Relief during Perineorrhaphy : A Randomized Controlled Trial

• Conditions: Pregnant women after vaginal delivery with 2nd or 3rd degree perineal tear and requires perineorrhaphy.; perineorrhaphy; Entonox; 50% nitrous oxide; Vaginal delivery; perineal tear

• Registration Number: TCTR20220503006
• Lead Sponsor: Faculty of Medicine Siriraj Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-03
• Study Completion: 2023-01-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: nknown
• Sex: Female
• Target Recruitment: 84

Inclusion Criteria

1.pregnant women with age of 18 or above
2.Vaginal delivery with perineal tear
3.2nd or 3 rd degree perineal tear
4.Volunteer participants

Exclusion Criteria

1.Patient with postpartum complication whic need immediate treatment
2.Patients who receive other anesthetic methods except local anesthesia by xylocaine injection at wound
3.Patients who receive pethidine injection within 2 hours before delivery
4.Patients with anemia and abnormal red blood cells size
5. Patients with intrauterine fetal death
6. Patients with perineal lesion
7. Patients with abnormal sensation at lower body part, below umbilicus
8. Patients with drug allergy to xylocaine
9. Patients who can not communicate influently in Thai or can not understand consent form before sign
10. Patients who contraindicated for using nitrous oxide e.g. pneunmothorax, pneumopericardium, severe bullous emphysema, gas embolus, severe head trauma, recent intraocular injection of gas, heart failure, severe impaired cardiac function, cognitive dysfunction, sign of increase intracranial pressure, vitamin B12 deficiency, folic acid deficiency, facial injury, recent dive, recent cardiopulmonary bypasswith heart-lung macne, coronary bypass without heart-lung machine

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain score at 5 minutes after finish and discontinue all invertions after perineorrhaphy Visual analog scale

Secondary Outcome Measures

Name	Time	Method
satisfaction at 5 minutes after finish and discontinue all invertions after perineorrhaphy questionaire