A Randomized Control Trial on Intravenous Paracetamol Versus Intramuscular Tramadol as Intra Partum Labor Analgesia

NCT06371144 | Completed Phase 2

• 1 other identifier: NHREC/16/05/22/130
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

Brief Summary

ABSTRACT BACKGROUND: Labor pain is one of the most excruciating pain experienced by women. It affects maternal psychology and the course of labor causing apprehension, anxiety, and stress. Therefore there is a need for a safe and effective analgesic with minimal maternal and fetal side effects like intravenous paracetamol which has been shown to have great analgesic effect in labour with minimal maternal and neonatal side effects. OBJECTIVE: To compare intravenous paracetamol versus intramuscular tramadol as labour analgesia and to evaluate the incidence of side effects on mother and baby of both drugs. METHOD: This would be a hospital based randomized controlled trial comparing intravenous paracetamol to intramuscular tramadol as labour analgesia in pregnant women in active phase of labour in the department of obstetrics and gynecology at Alex-Ekwueme Federal University Teaching Hospital and St. Patrick Mile 4 hospital, Abakaliki. A total of 194 pregnant women in active phase of labour will be included in study after fulfilling the inclusion criteria. These women will be divided into 2 groups of 97 each. Group A will receive a 100ml intravenous infusion containing 1000mg of paracetamol single dose over 15min. Group B: will receive intramuscular tramadol hydrochloride 100mg single dose. Pain intensity of women with both drugs will be noted before administration of drug, one hour, two hours and three hours after administration of drug using the visual analog scale. Perinatal outcome will also be recorded. 10 ANALYSIS AND RESULTS: Data will be collated, tabulated and then statistically analyzed using Statistical Package for Social Science (IBM SPSS) software (version 24, Chicago II, USA). Continuous variables will be presented as mean and standard deviation (Mean ± 2SD) or median and range as appropriate, while categorical variables will be presented as frequencies and percentages. Chi-square test( or Fisher's exact test where applicable) will be used for comparison between groups for categorical variables while student t test or Mann-Whitney U test will be used for comparison between groups for continuous variables KEYWORDS Labour analgesia, intravenous paracetamol, intramuscular tramadol, visual analog scale, neonate, side effects.

Conditions

Pain

Keywords

Labour analgesia, paracetamol, tramadol

Outcome Measures

Primary Outcomes (1)

• Mean pain score

  A standardized scale will be used to asses the mean pain score

  4hours following administration of each agent

Study Arms (2)

Paracetamol group

EXPERIMENTAL

Receive intravenous paracetamol intrapartum as labour analgesia

Drug: Paracetamol

Tramadol group

ACTIVE COMPARATOR

Receive intramuscular tramadol intrapartum as labour analgesia

Drug: Paracetamol

Interventions

Paracetamol DRUG

Analgestic

Also known as: Acetaminophen

Paracetamol group; Tramadol group

Eligibility Criteria

• Age: 15 Years - 45 Years
• Gender Eligibility Details: women in labour
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pregnant women carrying live singleton fetuses at 37-42 weeks' gestational age.
• Pregnant women in active phase of labour; cervical dilatation ≥ 4cm
• Spontaneous onset of labour.
• Singleton pregnancy with vertex presentation

You may not qualify if:

• Women with clinical evidence of cephalopelvic disproportion
• Malpresentation
• Multiple pregnancy
• Previously scarred uterus (post myomectomy, post caesarean)
• Preterm labour
• Induced labour
• Antepartum hemorrhage
• Pregnancy induced hypertension
• History of known allergy to tramadol and paracetamol or opioids
• History of medical disorders
• Fetal distress
• Intrauterine fetal death
• Refusal to give consent

Sponsors & Collaborators

• Darlington-Peter Chibuzor Ugoji: lead

Study Sites (1)

AEFUTHA

Abakaliki, Ebonyi State, 234, Nigeria

Location

MeSH Terms

Conditions

Pain

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• OGBO DR UZOMA, MBBS

  Alex Ekwueme Federal University Teaching Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Double blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr

Model Details: To compare intravenous paracetamol versus intramuscular tramadol as labour analgesia and to evaluate the incidence of side effects on mother and baby of both drugs

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: April 17, 2024
• Study Start: June 3, 2022
• Primary Completion: September 10, 2022
• Study Completion: September 10, 2022
• Last Updated: April 17, 2024

Record last verified: 2024-04

Locations

NG (1)