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Comparison of ketamine with tramadol in combination with acetaminophen for patients with abdominal pain presenting to the emergency department

Comparison of sub dissociative dose ketamine and tramadol in combination with acetaminophen for acute pain management in patients with abdominal pain presenting to the emergency department – An exploratory randomized double-blind study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/10/046261
Enrollment
60
Registered
2022-10-07
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: R109- Unspecified abdominal pain

Interventions

Intervention1: Low dose ketamine: Ketamine 0.1 - 0.3 mg/kg in 100 ml over 15 minutes Control Intervention1: Inj. Tramadol: 1mg/kg in 100 ml NS over 15 minutes

Sponsors

AIIMS Rishikesh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age 18 years and older. 2. Patients presenting to the emergency with abdominal pain within 7 days of onset. 3. Initial pain score of 4 or more on a standard 11-point (0-11) numerating rating scale.

Exclusion criteria

Exclusion criteria: Not willing to give consent. 2. Pregnancy 3. Altered mental status 4. Allergy to ketamine, opioids and acetaminophen 5. Severe hepatic insufficiency 6. Unstable vital signs (systolic blood pressure <90 or >180 mmHg, pulse rate of <50 or >150 per minute, respiratory rate of >30 or <10 per minute.) 7. Ischemic heart disease 8. Head injury 9. Stroke 10. Acute alcohol intoxication 11. History of drug abuse 12. Psychiatric illness

Design outcomes

Primary

MeasureTime frame
To assess and compare the change in pain scores in the two groups measured by numerical rating scale (NRS) at 30 minutesTimepoint: 30 minute

Secondary

MeasureTime frame
1. To assess and compare the change in pain score measured by NRS at 15min for onset of pain reliefTimepoint: 15 minutes;2. To assess and compare the change in pain score 60 and 120 minutes respectivelyTimepoint: 60 minutes and 120 minutes;3. To assess the incidence of adverse effects of the two groupsTimepoint: 0, 30, 60 and 120 minutes

Countries

India

Contacts

Public ContactAnirban

ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RISHIKESH

poonam.em@aiimsrishikesh.edu.in8477987835

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026