PainNCT00474721
Comparison of Acetaminophen With Codeine and Ibuprofen for Children With Injuries
A study testing ibuprofen and acetaminophen with codeine in people with Pain, run by University of California, San Diego at 1 site in United States.
Trial summary
We compared the pain relief of acetaminophen with codeine versus ibuprofen for children ages 5-18 years who came to the Pediatric Emergency Department with injuries to their arms or legs. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Pain
- What is being tested?
- ibuprofen and acetaminophen with codeine
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2002to Feb 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 5 to 18 years of age
- Spoke English as a primary language
- Complained of an extremity injury with tenderness to palpation from the clavicle or femoral neck to the distal phalanges
- Scored 5 or greater on a 10-point ordinal or Varni-Ryan pain scale administered at triage
Who cannot join
- Allergy or prior adverse reaction to acetaminophen, codeine or ibuprofen;
- Administration of any analgesic within 6 hours of presentation;
- Significant deformity or vascular insufficiency of the extremity requiring immediate treatment as determined by the treating physician;
- Inability to use the study pain instrument;
- Any laceration near the suspected injury;
- Chronic hepatic or renal disease;
Show all 9Show fewer
- Pregnancy in the third trimester;
- Concurrent use of contraindicated medications such as monoamine oxidase inhibitors; or
- Use of central nervous system depressants such as ethanol, benzodiazepines, barbiturates, antidepressants, or recreational drugs
Trial locations and contacts
1 site in 1 country.
United States1 site
Rady Children's Hospital
San Diego, California, 92123
About this study
Official title: A Randomized Blinded Comparison of Acetaminophen With Codeine and Ibuprofen for Treatment of Acute Pain in Children With Extremity Injuries
We compared the pain relief of acetaminophen with codeine versus ibuprofen for children ages 5-18 years who came to the Pediatric Emergency Department with injuries to their arms or legs.
Read the detailed description
We conducted a randomized, double-blinded equivalence trial. Pediatric Emergency Department patients 5-18 years of age with acute extremity pain received acetaminophen-codeine (1 mg/kg as codeine) or ibuprofen (10 mg/kg). They provided Color Analog Scale pain scores at baseline and at 20, 40, and 60 minutes after medication administration. The primary outcome measured was the difference in changes in pain score at 40 minutes, compared against a previously described minimal clinically significant change in pain score of 2 cm. Additional outcomes included need for rescue medication and adverse effects.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ibuprofenDrug
acetaminophen with codeineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in color analog scale pain score
Measured: 40 minutes
Secondary outcomes (3)
adverse reaction
Measured: during ED stay
need for rescue medication
Measured: during ED stay
Change in pain score
Measured: 20 and 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2007 (estimated)
- Study startNov 2002
- Study completionFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Investigators
- Janet H Friday, Principal investigator, UCSD, Dept of Pediatrics and Rady Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00474721
- Sponsor's protocol ID
- RCHSD10926
- Status last verified
- May 2007
- First submitted
- 16 May 2007
- Last updated
- 17 May 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Blinded Comparison of Acetaminophen With Codeine and Ibuprofen for Treatment of Acute Pain in Children With Extremity Injuries
- ClinicalTrials.gov ID
- NCT00474721
- Acronym / sponsor ID
- RCHSD10926
- Conditions
- Pain
- Keywords
- child, pain, analgesics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Nov 2002
- Study completion
- Feb 2004 (actual)
- First posted
- 17 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We compared the pain relief of acetaminophen with codeine versus ibuprofen for children ages 5-18 years who came to the Pediatric Emergency Department with injuries to their arms or legs.
Detailed description
We conducted a randomized, double-blinded equivalence trial. Pediatric Emergency Department patients 5-18 years of age with acute extremity pain received acetaminophen-codeine (1 mg/kg as codeine) or ibuprofen (10 mg/kg). They provided Color Analog Scale pain scores at baseline and at 20, 40, and 60 minutes after medication administration. The primary outcome measured was the difference in changes in pain score at 40 minutes, compared against a previously described minimal clinically significant change in pain score of 2 cm. Additional outcomes included need for rescue medication and adverse effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 5 to 18 years of age
- Spoke English as a primary language
- Complained of an extremity injury with tenderness to palpation from the clavicle or femoral neck to the distal phalanges
- Scored 5 or greater on a 10-point ordinal or Varni-Ryan pain scale administered at triage
Key exclusion criteria (9 listed)
- Allergy or prior adverse reaction to acetaminophen, codeine or ibuprofen;
- Administration of any analgesic within 6 hours of presentation;
- Significant deformity or vascular insufficiency of the extremity requiring immediate treatment as determined by the treating physician;
- Inability to use the study pain instrument;
- Any laceration near the suspected injury;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ibuprofen | Drug | – |
| acetaminophen with codeine | Drug | – |
Primary outcome
Change in color analog scale pain score
Time frame: 40 minutes
3 secondary outcomes
adverse reaction
Time frame: during ED stay
need for rescue medication
Time frame: during ED stay
Change in pain score
Time frame: 20 and 60 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janet H Friday principal investigator
UCSD, Dept of Pediatrics and Rady Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ibuprofen and acetaminophen with codeine in people with Pain, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in color analog scale pain score (time frame: 40 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2007.